978 Document Management Jobs - Page 35

Job Title: Legal Executive Location: Bangalore, Karnataka Department: Legal Experience Required: 1-4 years Industry: Agribusiness / FMCG Key Responsibilities: Act as the regional legal representative for Godrej Agrovet in Bangalore. Draft, review, and vet various legal agreements and contracts. Handle litigation including filing and defending suits for and against the company. Manage criminal cases, liaise with police, and coordinate service of summons and warrants. Conduct due diligence and verification of documents. Maintain legal records and documentation for all immovable properties. Liaise with external legal counsel, law firms, and statutory authorities. Provide legal support for recovery of dues, including travel to meet debtors. Advise business units on statutory and regulatory compliance Represent the company in courts and before regulatory bodies. Support the marketing team with credit appraisals of customers and distributors. Ensure compliance reporting through legal compliance software (e.g., Lexcare). Travel to company factories and locations across Karnataka, Tamil Nadu, AP/TN and other regions as needed. Required Skills & Qualifications: Education: LLB (mandatory); LLM (preferred). Strong knowledge of laws , contract law , and regulatory frameworks . Experience in litigation, property law, and compliance management. Proficiency in English and Kannada ; knowledge of Tamil and Telugu is an added advantage. Willingness to travel frequently and work on short notice. Preferred Attributes: Excellent communication and negotiation skills. Strong analytical and problem-solving abilities. Ability to work independently and manage multiple legal matters simultaneously. Familiarity with compliance tools and legal tech platforms.

Candidates should have a minimum of 10 - 12 years of management experience in a P&C or Specialty Insurance BPO service provider Expert in US P&C Insurance Understanding of end to end Claims handling Tools using in P&C Insurance Required Candidate profile Practical know-how of using MS Office application Mandatory: Graduate or Postgraduate from any background Desirable: Insurance / Risk management Commitment to achieving deadlines Good communication

Candidates should have a minimum of 2 to 4 years of experience in handling a team in a P&C or Specialty Insurance BPO service provider Must have managed the FNOL & FROI Processes Good Communication Required Candidate profile Practical know-how of using MS Office application Mandatory: Graduate or Postgraduate from any background Desirable: Insurance / Risk management Commitment to achieving deadlines Good communication

Candidates should have a minimum of 2 to 4 years of experience in handling a team in a P&C or Specialty Insurance BPO service provider Must have managed the FNOL & FROI Processes Good Communication Required Candidate profile Practical know-how of using MS Office application Mandatory: Graduate or Postgraduate from any background Desirable: Insurance / Risk management Commitment to achieving deadlines Good communication

Candidates should have a minimum of 10 - 12 years of management experience in a P&C or Specialty Insurance BPO service provider Expert in US P&C Insurance Understanding of end to end Claims handling Tools using in P&C Insurance Required Candidate profile Practical know-how of using MS Office application Mandatory: Graduate or Postgraduate from any background Desirable: Insurance / Risk management Commitment to achieving deadlines Good communication

We are looking for a proactive and detail-oriented Executive Assistant (EA) to support our Director in day-to-day operations, communication, and administrative tasks. The ideal candidate will also assist with basic digital marketing activities , helping enhance our online presence and outreach. This role is perfect for someone who thrives in a fast-paced environment, is tech-savvy, and can juggle multiple responsibilities efficiently. Key Responsibilities :- Manage the Directors calendar, appointments, meetings, and travel schedules Handle confidential documents and maintain effective filing systems Draft emails, reports, presentations, and other business correspondence Coordinate internal and external communications on behalf of the Director Assist in preparing agendas, taking meeting minutes, and following up on action items Manage expense reports, reimbursements, and related administrative tasks Help manage and update company website and social media platforms (LinkedIn, Instagram, etc.) Assist in creating basic graphics, posts, and newsletters using tools like Canva or Mailchimp Required Skills & Qualifications:- 24 years of experience in executive assistance, office administration Excellent verbal and written communication skills Strong organizational, time-management, and multitasking abilities Proficient in MS Office Suite (Word, Excel, PowerPoint) and Google Workspace Basic knowledge of digital marketing tools (Canva, Meta Business Suite, Mailchimp, etc.) Ability to handle confidential information with discretion Positive attitude and a willingness to learn and take initiative

The HR Shared Services Global Process Owner (GPO) will focus on the following Hire to retire processes: Voluntary In-Voluntary Separations. Core HR - employee life cycle / data changes. Contracts Records / Document Management. The GPO will drive as-is process review / discovery, measurement, improvement opportunity identification, to-be design, lead solution design for transition to shared services and emplace process governance. Required Skills: A bachelor s degree in a human resources or business-related field. Graduate degree desirable in a related field preferred. Minimum 4 to 6 years experience in HR consulting and/or shared services operations, demonstrable and proven expertise in HTR focus areas specified in role purpose. Global experience in transformation and process design work preferable with Oracle HCM system. Prior experience as GPO in focus areas an advantage. Process knowledge, process mapping experience and subject matter expertise related to focus areas. Program and project management experience required. Formal continuous improvement (e.g. Lean / Six Sigma) desirable. Experience using process mapping tools such as Microsoft Visio. Strong data analytics and excel skills for process analysis is a must. Preferred Skills: Business acumen and appreciating how a single change in a process can have a wide impact, and, conversely, how one change in the business can affect a particular process, is essential. Ability to think strategically while maintaining a strong sense of service delivery awareness. Strong facilitation and stakeholder management skills. Confident presenter for all audience types. Ability to manage competing initiatives. Effective interpersonal, verbal and written communication skills. Ability to multi-task, be self-managed and meet critical deadlines with limited supervision. #LI-AG1 Process Design, Documentation and Governance Define the L1 - L4 process taxonomy, map the process (L4 activities / L5 tasks), identify key areas for improvement including automations, implement improvement initiatives, and monitor and measure these initiatives with HRSS CI team. Build best-in-class, standardized processes, developing supporting process documents: process maps, workflows, standard operating procedures, process analytics business case. Work with KM team to develop HR knowledge articles to communicate process changes and strengthen process knowledge for HR community, managers and employees. Build and maintain partnerships with HR and Technology partners and be recognized within and across the HR function as the go-to expert and owner of process - no process change happens without the GPO s engagement. Provide HR process solution design for shared service migrations and migration support. Monitor user compliance; tracking where, and how well, the required process is being followed by the users. Support in any system implementation / enhancement initiatives to the extent impacting HR processes. Establish and sustain process change control for all HR processes. Process analysis and metrics Conduct robust process analysis (activity data collection - volume, time-spend, cycle time, headcount, FTE ratios). Work with shared services team to benchmark and set operational SLAs and KPIs. Process optimization (collaboration with HRSS CI) Collaborate with HRSS CI specialist to: Develop pipeline of process related improvements and opportunities with focus on leaner processes, reducing process costs, increasing efficiency, enhancing the user experience and drive better business outcomes. Conduct adequate and timely root cause analysis to understand problem drivers and implementation of necessary corrections and/or changes. Execute process optimisation initiatives, including driving process automation and RPA initiatives, working in collaboration with Technology and CI teams. Build business cases to quantify the cost and value of process opportunities and advocate for funding as necessary.

Provide management and service delivery excellence of (Clinical Event Validation and Adjudication) CEVA, OGM (Oversight Group Management) projects, as assigned by CEVA Management, covering single or multiple CEVA-OGM functions, with supervision from project oversight. Provide administrative coordination for Oversight Groups (Data Monitoring Committees, Safety Monitoring Committees and Steering/Advisory Boards) as assigned with minimal support. Provide leadership and accountability for all aspects of assigned projects. Essential Functions Manage customer interface and communication for assigned projects. Represent Clinical Event Abjudication (CEVA) on assigned projects as primary point of contact within CEVA for all internal and external customers. Liaise between internal/external customers inclusive of members.; Manage customer deliverables for assigned projects with minimal support. Tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, central filing, and archiving records), defining project/scope management, quality management, and project financial management under guidance of CEVA Management, as needed. Develop, finalize, and distribute all project-specific CEVA documents. Ensure compliance to IQVIA high quality standards and work within a matrix framework to achieve project and customer deliverables. Execute administrative tasks as required. Collaborate with CEVA Management to achieve departmental goals i.e. understand quality document management and assist in the achievement of productivity, quality, compliance, utilization, and realization metrics. Provide support for customer service interface from scoping stage, through proposal generation, bid defense to service delivery and throughout the development and commercial lifecycle of the product.; Manage realization/profitability for assigned projects under guidance from CEVA project oversight. Work closely with CEVA project oversight to update financial systems, including revenue recognition, invoicing, forecasting, project budget review, project financial analysis, pursuit of change orders. Develop specialist expertise in aligned areas. Attend meetings with internal and external stakeholders under guidance of CEVA Management as needed. Provide project status updates. Define processes, and project planning/strategy. Provide feedback to CEVA project oversight resource and Line manager on any challenges/issues and successes.; Drive business growth by improving customer loyalty through enhanced customer relations and service delivery excellence as guided by Line manager. Contribute in audits and inspections for assigned projects. Liaise with Quality Assurance staff and knowledge and quality management team in the compilation of Corrective and Preventive Action Plans. Upon sponsor customer approvals, locate and contract members and handle financial aspects. Onboard members and training them on roles and responsibilities. Perform project meeting management including logistics planning and conduct. Serve as back-up for other CEVA Specialists as assigned. Under the guidance of CEVA Management, establish mutually agreed upon working practices with customer, for standardized implementation across projects. Track and document project progress at all project phases (start-up, operations and close-out) and identify risks and develop mitigation plans. Work closely with CEVA project oversight and/or Line manager to address problem areas and customer needs. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs), customer SOPs and e-Trainings as required. Ensure all required training is executed within a timelines and documented. Ensure individual training plan and training transcript reconcile. Qualifications Bachelors Degree Nursing Degree or Bachelors degree in life sciences or educational equivalent in health science or other directly related field and clinical trial knowledge; or equivalent combination of education, training, or experience. Req Or Equivalent combination of education, training and experience Req 3 years Clinical Research Experience Req Working knowledge of Clinical Event Abjudication (CEVA) services. Familiarity with functionality of the Endpoint Tracking Database. Basic knowledge of applicable global, regional, local clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating Procedures (SOPs).; Ability to meet deadlines, manage competing priorities and changing demands.; Sound organization and time management skills. Ability to follow instructions/guidelines, work independently, and on own initiative. Attentiveness to detail and accuracy and ability to maintain high quality standards. Demonstrate effective IT skills. Effective written and verbal communication skills. Ability to be flexible and receptive to changing process demands. Willingness and aptitude to learn new skills across CEVA service lines. Ability to establish and maintain effective working relationships with co-workers, managers and clients.

For our business, for clients, and for you Transfer Agency Trade Processing Team Business- AML/KYC Role Title- Associate/Senior Associate The Transfer Agency Department provides Fund Administration services to numerous Fund management companies covering the full range of shareholder servicing functions including Transaction processing, Reporting, AML and Registration and Payments. The department is responsible for Client and investor document management, processing and quality checking of transactions and updating the registers of clients in response to investor instructions. This role is to perform BAU activities in the TA department to ensure that not only Client Service Level Agreements are consistently met and/or exceeded but also to ensure that regulatory requirements are effectively met. Candidates should be flexible enough to work in 24*7 environment. Key duties and responsibilities Individual/You should be able to perform quality reviews for all entity types. i.e Corporates, foundation/ Charities, institutional Investors, designated bodies etc, based on the Anti-Money Laundering (AML) policies and guidelines. Individual/You should be able to identify and document the results of the quality reviews and proposed remedial actions. Individual/You should be able to provide clear feedback to associates and coaching as needed. Individual/You should be well versed with any or all AML guidance for Cayman, Delaware, Australia, Ireland, Bermuda etc. Individual/You should have working knowledge of any or all of screening tools viz. World Check, Pythagoras, Lexus-Nexus etc. Individual/You should be well versed with Microsoft applications. Expertise in excel and presentation skills is an added advantage. Individual/You should have working knowledge of FATCA/CRS reporting. He/She should be able to review US tax forms i.e., W9, W8-BEN, W8-IMY, Withholding statements etc. Individual/You should have good written and verbal communication skills. Individual/You should be able to keep records in good order and perform regular remediation activities as per the risk rating of investors. Individual/You should be able to work separately and also collectively in a group as the situation demands. Individual/You should be able to create the required reports in time, without any reminders. Positive attitude and team spirit is a must. Prior experience in Transfer agency functions will be an added advantage. Qualification and Experience Flexible enough to work in any shift as per business needs. Prior Transfer Agency processing experience is required. Bachelor s degree in commerce is desired. 1-10 years of relevant experience Skills Required Strong analytical skills Responsible for meeting all client deliverables. Ability to navigate proficiently in a window environment. Strong knowledge of Microsoft Excel Word. Ability to write messages in a clear and concise manner. Ability to read, write speak English proficiently. Strong research, resolution, and communication skill Interpersonal skills - Relationship builder, respectful and resolves problems. Communication skills - Presentation skills, listening skills, oral written communication skills. Self-management - Adaptability and resilience, learning behavior, integrity and ethics and relationship build. Motivational skills - Performance standards, achieving results and persistence. Innovative thinking - Creative thinking decision making, input seeking, logical thinking and solution finding. Attention to detail and ability to work on multiple tasks. Flexible enough to work in any shift as per business needs. Prior Transfer Agency processing experience is required. Bachelor s degree in commerce is desired. 1-10 years of relevant experience Career with Apex A genuinely unique opportunity to be part of an expanding large global business. Exposure to all aspects of the business, cross-jurisdiction and to working with senior management directly.

For our business, for clients, and for you Transfer Agency Trade Processing Team Business- AML/KYC Role Title- Associate/Senior Associate The Transfer Agency Department provides Fund Administration services to numerous Fund management companies covering the full range of shareholder servicing functions including Transaction processing, Reporting, AML and Registration and Payments. The department is responsible for Client and investor document management, processing and quality checking of transactions and updating the registers of clients in response to investor instructions. This role is to perform BAU activities in the TA department to ensure that not only Client Service Level Agreements are consistently met and/or exceeded but also to ensure that regulatory requirements are effectively met. Candidates should be flexible enough to work in 24*7 environment. Key duties and responsibilities Individual/You should be able to perform quality reviews for all entity types. i.e Corporates, foundation/ Charities, institutional Investors, designated bodies etc, based on the Anti-Money Laundering (AML) policies and guidelines. Individual/You should be able to identify and document the results of the quality reviews and proposed remedial actions. Individual/You should be able to provide clear feedback to associates and coaching as needed. Individual/You should be well versed with any or all AML guidance for Cayman, Delaware, Australia, Ireland, Bermuda etc. Individual/You should have working knowledge of any or all of screening tools viz. World Check, Pythagoras, Lexus-Nexus etc. Individual/You should be well versed with Microsoft applications. Expertise in excel and presentation skills is an added advantage. Individual/You should have working knowledge of FATCA/CRS reporting. He/She should be able to review US tax forms i.e., W9, W8-BEN, W8-IMY, Withholding statements etc. Individual/You should have good written and verbal communication skills. Individual/You should be able to keep records in good order and perform regular remediation activities as per the risk rating of investors. Individual/You should be able to work separately and also collectively in a group as the situation demands. Individual/You should be able to create the required reports in time, without any reminders. Positive attitude and team spirit is a must. Prior experience in Transfer agency functions will be an added advantage. Qualification and Experience Flexible enough to work in any shift as per business needs. Prior Transfer Agency processing experience is required. Bachelor s degree in commerce is desired. 1-10 years of relevant experience Skills Required Strong analytical skills Responsible for meeting all client deliverables. Ability to navigate proficiently in a window environment. Strong knowledge of Microsoft Excel Word. Ability to write messages in a clear and concise manner. Ability to read, write speak English proficiently. Strong research, resolution, and communication skill Interpersonal skills - Relationship builder, respectful and resolves problems. Communication skills - Presentation skills, listening skills, oral written communication skills. Self-management - Adaptability and resilience, learning behavior, integrity and ethics and relationship build. Motivational skills - Performance standards, achieving results and persistence. Innovative thinking - Creative thinking decision making, input seeking, logical thinking and solution finding. Attention to detail and ability to work on multiple tasks. Flexible enough to work in any shift as per business needs. Prior Transfer Agency processing experience is required. Bachelor s degree in commerce is desired. 1-10 years of relevant experience Career with Apex A genuinely unique opportunity to be part of an expanding large global business. Exposure to all aspects of the business, cross-jurisdiction and to working with senior management directly.

About the Role: We are seeking a highly organised Legal Lead with 3 - 5 years of relevant experience to support our legal team. The ideal candidate will have a strong background in corporate legal documentation, regulatory compliance, and vendor management processes. Key Responsibilities: Draft, review, and manage a variety of corporate agreements, including: Service Agreements Master Service Agreements (MSAs) Data Processing Agreements (DPAs) NDAs and other commercial contracts Support regulatory compliance initiatives, ensuring adherence to applicable laws and internal policies. Manage vendor due diligence, including completing vendor questionnaires and reviewing third-party documentation. Assist in responding to security and privacy-related questions from clients and partners. Maintain and update internal contract databases and track key legal documentation. Coordinate with internal stakeholders including procurement, finance, and IT on contract-related issues. Support the legal team in preparing documentation for audits or regulatory inspections. Requirements: Bachelor s degree and/or paralegal certification preferred. 3 - 5 years of experience in a legal assistant or paralegal role, preferably within a corporate legal department or law firm. Solid understanding of corporate agreements, data protection, and regulatory compliance. Experience handling vendor security questionnaires and information security topics. Excellent written and verbal communication skills. Strong organisational and time-management abilities. Proficient with MS Office Suite, Google Workspace, and document management systems. Preferred Qualifications: Familiarity with GDPR, CCPA, or similar data privacy regulations. Experience working in tech, SaaS, or regulated industries. Ability to work independently and manage multiple priorities in a fast-paced environment.

Role & responsibilities Data entry into legal software Preparation of MIS reports in Excel Scanning legal documents and uploading them into the system Legal documentation filing and related administrative work Preferred candidate profile Graduate with relevant experience Basic to advanced excel skill required Interested candidates can reach on Ph:-+91 91364 48232 Email -ID :- minima.nagmani@calibehr.com

GIC is one of the worlds largest sovereign wealth funds With over 2,000 employees across 11 offices around the world, we invest in more than 40 countries globally across asset classes and businesses Working at GIC gives you exposure to an extraordinary network of the worlds industry leaders As a leading global long-term investor, we Work at the Point of Impact for Singapores financial future, and the communities we invest in worldwide, GIC Private Equity (PE) GIC is a global investment firm and has one of the largest and broadest private equity programmes amongst all institutions GIC PE invests across the Americas, Europe and the Asia-Pacific in a range of sectors including Healthcare, Consumer, Financial services, Technology, Industrials, Sustainable Energy and Infrastructure Besides investing through private equity fund managers, GIC PE also invests across the capital structure in equity, senior and junior debt, in secondary PE deals, restructuring & opportunistic credit and special situations We currently have over 100 active relationships with fund managers and have invested directly in more than 1000 companies globally across multiple sectors, Transaction Management The role of a Transaction Manager (TM) in GIC is to work in-step with the investment teams to project manage the smooth and timely closings of investments within the GIC private markets The Transaction Manager will execute a variety of projects and tasks related to deal closing and investment operations across a number of strategies, What will you do as a Transaction Manager Review, manage and file all necessary forms, declarations and submissions for external Director appointments on new and existing deals, Ensure compliance with any additional regulatory requirements regarding Director appointments, Review board meeting materials and prepare Directors for up-coming meetings to ensure all necessary information is documented and any prior approvals are obtained, Follow-up on post-meeting tasks, including verifying minutes and handling administrative duties, General compliance and regulatory filing assistance for new and existing deals, Review and manage NDAs in collaboration with internal teams and external counterparts, Ensure any restrictions are logged and managed in accordance with internal policies, Work in step with deal teams on timing of new investment approvals and closing requirements to operationalize, Work in close partnership with the wider Transaction Management team ensuring all closing requirements are met as per the service menu, Be the go-to resource for all process queries or application of processes and policies relating to the deal closing function, Collaborate with internal teams and be the point of contact for external counterparts to ensure timely exchange of KYC documentation and funding for new investments, Collect, record, update and reconcile quantitative and qualitative investment data for use in reports, projections, and analyses, maintain key term databases, What qualification or skills should you posses in this role Bachelors degree in Law, Business Administration, or a related field, Proven experience as a paralegal or legal assistant in a similar role, Strong understanding of corporate governance, corporate secretarial and compliance requirements, Strong understanding of Director fiduciary responsibilities, Excellent organizational and document management skills, Excellent communication and organizational skills with the ability to handle multiple tasks and deals at any given time, Ability to work independently and as part of a team, 3-5 yearsexperience in a similar role within the financial services industry, Work at the Point of Impact We need to be forward-looking to attract the right people to help us become the Leading Global Long-term Investor Join our ambitious, agile, and diverse teams be empowered to push boundaries and pursue innovative ideas, share your views, and be heard Be anchored on our PRIME Values: Prudence, Respect, Integrity, Merit and Excellence, which guides us in how we make our day-to-day decisions We strive to inspire To make an impact, Flexibility at GIC At GIC, our offices are vibrant hubs for ideation, professional growth, and interpersonal connection At the same time, we believe that flexibility allows us to do our best work and be our best selves Thus, our teams come into the office four days per week to harness the benefits of in-person collaboration but have the flexibility to choose which days they work from home and adjust this arrangement as situational needs arise, GIC is an equal opportunity employer GIC is an equal opportunity employer, and we value diversity We do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment, Please email grphrodtaops@gic sg at any point of the application or interview process if adjustments need to be made due to a disability, Learn more about our Private Equity Department here: https://gic careers/group/private-equity/ Our PRIME Values GIC is a values driven organization GICs PRIME Values act as our compass, enabling us to fulfil our fundamental purpose and objectives It is the foundational bedrock which governs our behaviors, our decision making, and our focus It informs both our long-term strategy as a firm, and the way we relate to our Client, business partners and employees PRIME stands for Prudence, Respect, Integrity, Merit and Excellence,

Select with space bar to view the full contents of the job information. Project Engineer-E3-Mechanical-Design Engineering Job Details | tatacons02 Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Project Engineer-E3-Mechanical-Design Engineering Pune, MH, IN, 411021 Purpose & Scope of Position The Project Engineer (PE) will be part of an engineering stream providing engineering services to large and small projects. The PE provides support to the Project Manager (PM) and Engineering Manager (EM) and is responsible for supervising a team of working engineer and designers. The PE provides leadership and assists in the resolution of all technical issues related to the discipline. Experience 10+ years of experience in relevant design discipline Experience in engineering and package coordination Qualification Postgraduate or graduate in an engineering discipline Registration as a professional engineer with the governing authority (preferable) Key Responsibilities 1. Assist the PM and EM with the delivery of project requirements as they relate to scope, quantities, cost and schedule 2. Prepare Engineering Work Packages (EWPs) in consultation with the Engineering Manager 3. Assist in the compilation and delivery of monthly engineering status reports 4. Participate in and contribute to design reviews 5. Represent the discipline in the project engineering coordination meetings 6. Prepare and/or review project procedures, standard specifications and design criteria 7. Review and evaluate technical work prepared by junior engineers, intermediate engineers, designers, technicians and technologists 8. Ensure relevant technical experts are involved in the design process as required and facilitate the sharing of technical expertise across projects 9. Perform conceptual and detailed engineering design 10. Prepare engineering work (calculations, reports, specifications, evaluations, recommendations etc.) where required 11. Provide and/or coordinate training for resources assigned to the project 12. Work to ensure the implementation of safety in design 13. Ensures measurement of progress on all contracts for reporting and progress claim purposes. 14. Responsible to ensure timely availability of discipline data to other disciplines, and work with fellow PEs and EM on integration of the same and resolution of any issues and challenges 15. Document value additions and best practices and ensure communication of the same to fellow project engineers of other projects and discipline leadership 16. Support technology team/ Project team for development and automation works as required. 17. Ensure compliance to all quality and document management processes within TCE and as agreed with customer. 18. Manage performance data of reportees and provide periodic feedback. 19. Provides resource loading forecast to TL. 20. Keeps records of learning s during the project and provides inputs to PM during job closure report. 21. Prepare technical specifications/ bid evaluation/ technical recommendation where required 22. Interact with the discipline engineers of customer during entire life cycle of the project and beyond.

The Technical Writer - Change Control Management is responsible for developing, managing, and maintaining documentation related to change control processes within a regulated manufacturing environment. This role ensures documentation accuracy, consistency, and compliance with regulatory and organizational standards. The Technical Writer will leverage their knowledge of science and manufacturing technologies to collaborate effectively with cross-functional teams, streamline documentation workflows, and support the organization s change control management processes. Key Responsibilities Develop, revise, and maintain high-quality documentation related to change control processes, ensuring alignment with cGMP and other regulatory standards. Collaborate with cross-functional teams, including Quality, Operations, and Engineering, to ensure all change control documentation is accurate, comprehensive, and aligned with organizational objectives. Utilize scientific and technical knowledge to accurately interpret and document manufacturing processes, equipment, and technology changes. Manage the lifecycle of change control documentation, including updates, version control, and accessibility for stakeholders. Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation. Standardize templates and formats for change control documentation to enhance consistency and usability across the organization. Provide support during audits and inspections by ensuring accurate and readily available change control documentation. Track and report on metrics related to change control documentation, including timeliness, compliance, and quality. Train and mentor team members on documentation best practices and change control management processes. Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows. Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting. Key Performance Indicators Accuracy and compliance of change control documentation Timeliness of documentation updates and approvals Stakeholder satisfaction with documentation quality and usability Adherence to regulatory requirements during audits and inspections Effectiveness of standardized documentation processes Skills: Good Documentation Practice Effective communicator Strong cross functional collaboration Adaptability to Embrace Change Effective stakeholder engagement Manufacturing Process Knowledge Of GMP (Good Manufacturing Practices) Change Control Deviation management Corrective and preventive action (CAPA) Continual Improvement Process General HSE Knowledge Manufacturing (Production) Background Education : bachelors degree in a science or engineering-related field (eg, Biology, Chemistry, Mechanical Engineering, or similar disciplines). Languages : English fluent Experience : 5+ years of experience in technical writing, preferably within a regulated manufacturing or scientific environment. 2+ year of experience in in drafting and managing change control documentation within GxP settings. Strong understanding of change control processes, cGMP, and regulatory compliance. Fundamental knowledge of science and/or manufacturing technologies, with the ability to interpret technical and scientific information. Proficient in document management systems and technical writing tools. Excellent attention to detail, organizational skills, and the ability to manage multiple priorities. Experience supporting audits and inspections is a plus. Familiarity with Lean principles or continuous improvement methodologies is advantageous. Proficiency in English (oral and written) is required

The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : Strategy and delivery of PCS deliverables for products under development and in-market. Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products. Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts. Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives. Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines. Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books. Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables. Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement. Act as a nonclinical scientific liaison to Submissions Documentation (SD) vendor supporting nonclinical submission document management. Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations. Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines. Essential Requirements: PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment Understanding of GLP principles in nonclinical studies and submission writing. Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development. Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred. Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred. Registration and certification with one of the International Toxicology registers. Desirable Requirement: Animal Models ,Communication Skills, Data Analysis. Ethics ,Laboratory, Problem Solving. Regulatory Compliance. Research. Risk Assessment. Toxicology

Summary Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working. About the Role The CDM Business Migrations Manager is responsible for effective planning and delivery of migrations to and from of Novartis enterprise-wide clinical electronic document management systems (eDMS) aligned to Novartis business needs, partnering with technical vendors, internal IT and business stakeholders. Drives implementation of CDGM initiatives, projects and process improvement activities to enhance the planning and execution of migrations to and from enterprise clinical eDMS at Novartis. Act as CDGM point of contact for partnering with CDGM, IT (internal and external) and business stakeholders to plan and execute migrations to and from eDMS, in line with Novartis business, compliance and operational requirements. Partner with CDGM and business stakeholders, especially those planning in-licensing and out-licensing activities to identify and agree migration business requirements, understand source and target system capabilities and develop/maintain a future migration roadmap. Contribute to activities to ensure efficient processes integrations of systems with eDMS based on strong understanding of Novartis enterprise systems landscape and in line with compliance and business priorities. Serves as Subject Matter Expert for training materials, formal and informal processes and tracking tools for eDMS migration activities, in collaboration with CDM Process team and other key stakeholders Plan and contribute to agile working methodologies being applied during development cycles to prepare for migration and during post migration hyper care period. Owner or Contributor of activities related to migration related Incident Management, Change Management and ongoing operations of the eDMS. Support forecasting of internal resource allocations and vendor provided activities as part of eDMS migration roadmap management. Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model in relation to migration. Acts as point of escalation for issues. Provides support for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs. Minimum Requirements: Advanced degree or combination of bachelors degree in information or life-sciences/healthcare and relevant industry experience. Minimum of 6 years working in Pharmaceuticals, Lifesciences and Clinical Research with specific experience in contributing and leading of clinical document management, TMF and/or records information management. Minimum of 5 years of full-scale migrations Minimum 2 medium to major Veeva related hands-on and provable experience in leading and planning of migrations. Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory highly desired. Business relevant technical and working experience of eDMS systems like Veeva Clinical vault, RIM, Documentum D2LS or similar Knowledge of industrywide Electronic and Clinical Document Management systems and features Deep knowledge of Agile way of working with cross functional teams for releases Strong influencing and presentation skills. Ability to communicate effectively at all levels

Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions. Major accountabilities: In collaboration with the clinical teams, compile, integrate and publish clinical documents with word processing, electronic publishing, and document management systems in the Novartis Development environment. Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents. Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements. Under direct supervision of the immediate manager, acts as the Program Publisher for various programs in clinical development. Key performance indicators: Publish clinical documents (taking into account complexity and size) in accordance with department standards and organization KPIs. Ensure published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and no rework once finalized. Timeliness of deliverables meet both individual document and overall project timelines. Minimum Requirements: Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria. Effective interpersonal skills, strong written and oral communication and presentation skills. Project management and time management skills to manage multiple ongoing projects simultaneously. Familiar with regulatory requirements and HA guidance, including FDA regulations, ICH and EMA guidelines/directives. Working knowledge of regulatory affairs. Works independently and with minimal supervision. Proficiency with computer programs/systems (MS office, etc) with demonstrated ability to learn new systems quickly. Analytical skills and problem solving skills. Ability to coordinate and work effectively with cross-functional teams. Work Experience: Cross Cultural Experience. Functional Breadth. Collaborating across boundaries. Operations Management and Execution. Project Management. Skills: Clinical Study Reports. Data Analysis. Documentation Management. Lifesciences. Operational Excellence. Regulatory Compliance. Languages : English.

Document Management Systems - AODocs, DocuSign Google Workspace Integration Tools Scripting & Automation Identity & Access Management Collaboration & Enablement Monitoring & Analytics ITSM & Support Platforms Architecture & Documentation Required Candidate profile Must - AODocs, Google Workspace, Microsoft 365 tools, SharePoint, OneDrive, MS Teams, Certification - ITIL v4, M365 Certified Enterprise Administrator Expert, GWS Admin Certification

Key Responsibilities: Project Planning: DPR, Yearly Budget preparation, Monthly Program, Bulk material scheduling, Monthly Report Preparation, three months look ahead program, Project Monitoring. Analyzing of Contract Document, MIS etc. Risk analysis, maintaining Hindrance register and Drawing register. Quantity Surveying (QS): Cross-checking of quantities from CAD/PDF drawings as per IS code guideline for Client billing and Sub-Contractor Billing, Evaluation & making action Plan accordingly. DC and IDC analysis (Cost analysis) and Revenue Recognition of the project. The analysis is based on the Direct cost (Based on the B.O.Q) and Indirect Cost (Over Head Cost) of the project with revenue for the project. Monthly Sales Preparation & Taking cost provision against un-booked cost to analysis profit and Loss. Resolve complex Issues quickly. Rate analysis vendor and extra items. Vendor Finalization and Procurement of Services for the project up to Site level. (PRW and Specialized Vendors). Representing Clint and consultant regarding drawing issues and site related issues. Attending all internal and external meetings. Cost Controlling- to help the project continuing profitability

For our business, for clients, and for you Transfer Agency Trade Processing Team Business- Dealing Role Title- Associate The Transfer Agency Department provides Fund Administration service to numerous Fund management companies covering the full range of shareholder servicing functions including Transaction processing, Reporting, AML and Registration and Payments. The department is responsible for Client and investor document management, processing and quality checking of transactions and updating the registers of clients in response to investor instructions. This role is to perform BAU activities in the TA department in order to ensure that not only Client Service Level Agreements are consistently met and/or exceeded but also to ensure that regulatory requirements are effectively met. Candidates should be flexible enough to work in 24*7 environments. Key duties and responsibilities Processing of Financial Non-Financial transactions through internal systems as per regulatory and client requirement Identify and resolve problems within the defined procedures. Complete archiving of investor and client documentation ensuring a full audit trail exists for subsequent retrieval Expected to work on initiatives/Ad-hoc requirements as per business needs. Should be able to work independently but also need to be a good team player. Should be able to identify process gaps need to work as a trouble shoot. Ability to support, guide train other team members. Should have the ability to understand handle complex queries Strong domain knowledge is essential understanding of TA business .es Well versed with preparation and review of SOPs/Process flow charts Able to identify implement various process control Provide innovative ideas for process enhancements Should have a good understanding of regulatory and audit requirements to ensure all the requirements are fulfilled Ability to prioritize multiple tasks by utilizing effective time management skills. Qualification and Experience Prior Transfer Agency processing experience is required Bachelor s Degree in Commerce is desires 1-5 years of relevant experience Skills Required Strong analytical skills Responsible for meeting all client deliverables Ability to navigate proficiently in a windows environment Strong knowledge of Microsoft excel word Ability to write messages in a clear and concise manner Ability to read, write speak English proficiently Strong research, resolution and communication skills Interpersonal skills - Relationship builder, respectful and resolves problems Communication skills - Presentation skills, listening skills, oral written communication skills Self-management - Adaptability and resilience, learning behaviour, integrity and ethics and relationship builder Motivational skills - Performance standards, achieving results and persistent. Innovative thinking - Creative thinking decision making, input seeking, logical thinking and solution finding. Attention to detail and ability to work on multiple tasks. Flexible enough to work in any shifts as per business needs Prior Transfer Agency processing experience is required. Bachelor s degree in commerce is desires. desirable 1-5 years of relevant experience Ability to work under pressure and should be able to handle multiple projects. A good understanding of effective risk management it s execution. Effective verbal reasoning and numeric skills Excellent planning and organization skills The candidate should be able to understand the intricacies of TA business it s impact on other related functions. Career with Apex A genuinely unique opportunity to be part of an expanding large global business. Exposure to all aspects of the business, cross-jurisdiction and to working with senior management directly.

Job Objective: Ensure that all relevant customer requirements are meticulously assessed, evaluated, negotiated, and implemented within the organization. Drive the identification and application of these requirements in an efficient and timely manner, ensuring no delays in the economic setup. Duties and Responsibilities: Customer Requirement Review: Proactively review and identify updated customer requirements from various customer portals, ensuring no detail is overlooked. Document Control: Execute stringent control of documents according to defined processes, including thorough checks and maintenance of results provided by automated uploads to the document management system. Requirement Assessment: Prepare comprehensive assessments of customer requirements using defined processes, tools, and methods, including the identification of similar requirements and their assessment results. Responsibility Reassignment: Efficiently reassign responsibilities to appropriate groups, ensuring clarity and accountability. Expert Communication: Maintain continuous communication with subject matter experts on various open topics, managing workflows effectively. Requirement Verification: Rigorously check every requirement in the Requirements Management System according to the process, assigning appropriate object statuses. Documentation: Accurately document assessment results according to stringent rules and standards. Process Improvement: Continuously improve and develop relevant processes, methods, and tools to enhance efficiency and effectiveness. Support and Training: Provide 2nd level support and train new Customer Requirement Documents (CRD) assessment experts on the corresponding process, methods, and tools. KPI Achievement: Ensure the achievement of monthly Key Performance Indicators (KPIs) with a focus on continuous improvement. Process Tracking: Provide detailed process indicators for tracking and monitoring process performance. Ticketing System: Establish and manage a robust ticketing system for dedicated services, ensuring timely resolution of issues. Data Security: Administer access rights in the Requirements Management System to ensure stringent data security. Support Activities: Provide support for clean-up and maintenance activities, such as cleaning up CRDs in NormMaster, as requested. Expert and Workflow Management: Maintain an up-to-date list of experts and active workflows, ensuring their currency and relevance. Mandatory Skills: Language Proficiency: Excellent command of English and Moderate at Chinese Language. Independence: Strong ability to work independently with minimal supervision. Adaptability: Readiness to tackle open topics and learn about other domains. Knowledge Sharing: Willingness to share own competencies and experience with the team. Open-mindedness: Being open-minded and receptive to new ideas and approaches. IT Affinity: Strong affinity for IT, especially regarding digitalization, AI, and new tools. Document Management: Experience in document management and control. Tools Proficiency: Proficiency with tools such as DOORs and Pro4B. Qualification Requirements: Bachelor of Engineering in Electronics is a must. 3-5 years of relevant experience in a demanding environment.

Job Description Job Title Client Service Support Specialist - TAS - Global Corporate Title Analyst Location Mumbai, India Role Description Overview Business Division Deutsche Bank s Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services, and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. Overview Business CB s Trust and Agency Services (TAS) team, with offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore, and Tokyo has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. The successful candidate will be required to cover European working hours supporting the business globally. Corporate title will depend on the relative experience of candidate. What we ll offer you As part of our flexible scheme, here are just some of the benefits that you ll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your Key Responsibilities As a central team provide support to the global Client Services teams on various day to day Client Service functions, these will include Annual Reviews, CCD Validation and Management, Deal Document management, Regulatory reporting etc. Support the requirement for Annual Client reviews working closely with the Client Service Teams ensuing accurate records are maintained and completed within the deadline. Work closely with the Offboarding teams to actively process the offboarding of clients due to termination of transaction. Monitor and update when required Key Operating Documents Produce reports for various risk and oversight councils. Work on standardization, process improvements and reengineering for on centralized functions. Your skills and experience Desired background MBA with experience in Financial Services Proficiency in other MS office tools such as Excel, Word Excellent verbal and written communication skills Experience in conducting and driving meetings with senior stakeholders and global teams A willingness to be flexible to meet changing work priorities and tasks, with an ability to manage a high workload, work independently and plan your work to meet deadlines An eye for detail, identify data discrepancies and exceptional problem-solving skills How we ll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs

Why Work at Rehlko We have met todays energy needs while planning for tomorrows for over 100 years. Beginning with the first modern generator, the Rehlko Automatic Power & Light, launched in 1920, Rehlko has been an innovative leader in energy resilience. Our product range includes engines, generators, power conversion, UPS systems, EV components and electrification solutions, microgrid controls and management, clean energy solutions, and much more that serve a broad spectrum of OEM, residential, industrial, and commercial customers. Our priorities are global: the stability from steady energy sources and reliable back-ups. The power to be able to harness energy, and the freedom of not being dependent on an aging centralized grid. The confidence that clean energy solutions offer when it comes to a sustainable world, and the commitment to keep innovating towards greater impact. Why You Will Love this Job : Job Description Our Environment, Health, Safety (EHS) and Facilities team is committed to fostering a safe and sustainable work environment for all employees. We strive to create a culture of safety and well-being by implementing comprehensive EHS programs that align with industry best practices and regulatory requirements. Primary Function As a part of Rehlko s corporate Environment, Health, Safety (EHS) and Facilities team, the Assistant EHS Manager will support the Company s EHS and Facilities strategy and initiatives by enabling a culture of data-driven decision making, system-supported problem solving, standardization, digitization, and simplification. This role will be accountable for: providing subject matter expertise, training, and management of Rehlko s EHS Management Information System (Gensuite); driving and promoting a zero-incident and 100% compliance culture throughout Rehlko; owning EHS programs and initiatives; and, supporting Facilities-related tasks. This position will report directly to Rehlko s Senior Director - EHS & Facilities. Key responsibilities of this role are as follows: Data Management System liaison for the Gensuite platform including injury/illness, environmental metrics, compliance obligations, event management, inspections, users and budget. Provide routine new user and module-specific training. Develop and lead the multi-year implementation of Rehlko s EHS data management system including driving awareness and accountability, monthly reviews, annual audits, CAPA tracking and writing SOPs. Develop dashboards and reports to track progress towards goals, respond to customer requests, provide external reports, and facilitate Operating Reviews. Respond to ad-hoc EHS and sustainability data requests. EHS Support Provide ownership, technical support and coordination of EHS activities, programs, tactical plans, campaigns and tools, as assigned. Participate on EHS audits, inspections, kaizen events and treasure hunts focused on savings and continuous improvements, regulatory compliance and Rehlko requirements. Manage configuration and content of the EHS SharePoint site and Teams channels. Facilitate company-wide EHS engagement and prepare announcements, alerts, and similar communications using social media, emails, messages and other systems. Maintain Rehlko s EHS Management System and document management requirements. Facilities Support and coordinate Facilities-related activities and programs, as assigned. Assignments may include Rehlko s fleet program, real estate, security, custodial, building maintenance, PO & invoice management support, etc. Education & Experience Bachelor s degree in environmental science, occupational safety, sustainability, or other related field required. 7-10 years of relevant EHS experience, preferably in manufacturing. Key Competencies Expert with PowerBI, Tableau, Alteryx, Microsoft Access, Excel, and/or other dashboard (report building) software. Excellent verbal and written communication skills with the ability to communicate and influence at all levels in the organization. Ability to work independently and manage priorities in a dynamic environment. Exceptional organization, time management and multi-tasking abilities. Up to 10% travel expected. Preferred Skills Experience supporting Facilities-related programs including real estate, security, and fleet. Strong working knowledge of environmental programs (waste, wastewater, air emissions, spill prevention, remediation) and compliance obligations. About Us Rehlko proudly offers a rich history steeped in creativity and commitment to our associates and communities, along with competitive benefits and compensation. Our Purpose Creating an energy resilient world for a better future and Values: Curiosity, Trust, Pace, and Excellence, are important cultural components that shape the way we work and relate to one another. Learn more about Rehlkoat https: / / www.rehlko.com / who-we-are.In addition to the investment in your development, Rehlko offers a benefits package including a competitive salary, health, vision, dental, 401(k) with Rehlko matching, and more!?" . Rehlko is an equal opportunity employer that prohibits discrimination and will make decisions regarding employment opportunities, including, but not limited to, hiring, job assignment, compensation, promotion, benefits, training, discipline, and termination, without regard to race, creed, color, ethnicity, religion, sex, pregnancy, childbirth, or related medical conditions, genetic information, age, national origin, citizenship, ancestry, caste, mental or physical disability, marital or familial status, sexual orientation, gender identity or expression, genetic information, political belief or affiliation, union membership status, military status, veteran status, or any other characteristic protected by national, state, local, or other applicable laws.

To Manage Regulatory Affairs for in compliance to applicable regulations and guidelines. This position will assist with the review of clinical/Biopharmaceutical/Non Clinical and labelling documentation, preparation and review of non-CMC sections, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg. Duties and responsibilities Providing high-quality Clinical, Biopharmaceutical, Pharmacokinetic, non-clinical review of CTD sections for regulatory filings to SRA (e.g EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia) as well as agencies of ROW markets for DDReg clients Actively contribute to the development and implementation of regulatory strategies, processes and timelines for global approval. Carrying out Gap Analysis of Non-CMC sections for small molecules and biopharmaceuticals Authoring, and compiling CTDs sections, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Prepare &/or review labelling documentation, managing labelling changes, prepare variation application on labelling changes, intended for submission to the above-mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Demonstrate subject matter and area expertise. Collaborate with internal and external clients. Supporting and enabling effective and efficient communication that results in operational excellence. Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website. Monitor competitive regulatory practices and actively review internal and external factors to mitigate potential problems. Ensure that draft labeling complies with all applicable regulations and guidelines Education & Experience Bachelor s or Master s degree in Pharma Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years ) or equivalent combination of education, training, & experience. Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and Abilities Excellent technical data interpretation skills Strong project management skills Excellent interpersonal skills including problem solving Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national and other document development guidelines In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Ability and desire to work in a team-oriented environment. Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner Possesses a collaborative, results-driven style. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines