1256 Regulatory Affairs Jobs - Page 2

**Job Description:** As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems. **Key Responsibilities:** - Lead validation efforts for drug safety systems such other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations). - Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matrices. - Perform risk assessments and impact analysis of software changes or upgrades to ensure compliance with validation requirements. - Collaborate with cross-functional teams (IT, Quality Assurance, Pharmacovigilance, and Compliance) to ensure effective implementation and maintenance of validated systems. - Provide guidance and training on validation processes and regulatory requirements. - Support audits and inspections related to CSV activities and respond to findings or inquiries from regulatory bodies. - Manage the CSV lifecycle, including requirements gathering, testing, and system releases for safety systems. - Ensure that all system-related issues are identified, tracked, and resolved in a timely manner. **Qualifications:** - Bachelor's degree in Computer Science, Life Sciences, or a related field (or equivalent experience). - Minimum of 2years of experience in Computer System Validation, with a focus on drug safety systems (Argus, ArisG, or similar). - In-depth knowledge of pharmaceutical and regulatory requirements, including 21 CFR Part 11, GxP, and ICH guidelines. - Strong experience in system validation and lifecycle management of computer systems, including testing, documentation, and quality assurance processes. - Familiarity with the pharmacovigilance domain and the processes for adverse event reporting and management. - Excellent communication and leadership skills with the ability to work in cross-functional teams. - Experience with audit readiness and regulatory inspections (FDA, EMA, etc.) is a plus. - Certification in Computer System Validation or related fields is a plus.

* B.Pharm/M.Pharm with 4-6 years in Regulatory Affairs, experience in dossier preparation, and country-specific formats. * Prepare dossiers, handle queries, manage re-registration and renewal applications.

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a wide range of products and services to customers across different geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Specialty Pharmaceuticals segment includes Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. Generics & APIs segment comprises Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing, respectively. The Mysore manufacturing site, spread over 69 acres, is USFDA approved and produces APIs targeting Lifestyle driven Therapeutic Areas. The Roorkee facility is state-of-the-art and approved by multiple regulatory bodies. Both manufacturing units are supported by around 500 research and development professionals working on new product development in API, Solid Dosage Formulations, Sterile Injectable, and other formulations. R&D facilities include an 80-bed unit for BA/BE studies. JGL's Regulatory Affairs & IPR professionals manage patents and product filings for regulatory and non-regulatory markets, ensuring a unique product portfolio. Jubilant Pharma's revenue has been growing consistently, reaching INR 53,240 Million during the Financial Year 2018-19 compared to INR 39,950 Million in the previous year. For more information about the organization, visit www.jubilantpharma.com.,

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Our people make all the difference in our success. Join us in our mission to advance the world of health. Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements. Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines. Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements. Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release. Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation. Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments. Review and approve labeling and promotional material for compliance to FDA and EU regulations. Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries. Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams. Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics. Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. Work independently and carries out the above tasks with minimal supervision. Education and Experience: B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations. Experience in supporting product development projects for product and process changes. Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. Proficient in using Microsoft Word, Excel, PowerPoint, and Project. Strong communication (written, oral) and project management skills. Able to handle multiple competing tasks with great attention to detail. Able to work independently to achieve objectives on or before schedule. Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. Comprehensive knowledge of medical device regulations and standards. Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation.,

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,

As a Quality Control (QC) Analyst at Jubilant Generics, you will be responsible for various tasks related to ensuring the quality and compliance of pharmaceutical products. Your role will involve sampling and analyzing packing materials and raw materials, conducting in-process quality control, and preparing specifications and test procedures. Additionally, you will be responsible for maintaining artwork and shade cards, as well as calibrating and validating instruments and equipment. Your attention to detail will be crucial in recording analytical data accurately and preparing records of analysis for both raw materials and finished products, including stability samples. In this role, it is essential to uphold cGMP (current Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance at all times. You will also be involved in investigating deviations, incidents, and out-of-specification results, ensuring that corrective actions are implemented promptly. Furthermore, maintaining a clean and organized work environment is important, and you will play a key role in ensuring good housekeeping practices in the laboratory. Your contribution to these quality control processes will ultimately support Jubilant Pharma's commitment to delivering high-quality pharmaceutical products to customers worldwide. For more information about Jubilant Pharma and its operations, please visit www.jubilantpharma.com.,

The Clinical Research Scientist position at NIRAMAI Health Analytix requires a Strong Leader, Clinical Specialist, and Medical Expert with an entrepreneurial mindset to lead the clinical research and marketing division. Your role will be crucial in furthering NIRAMAI's mission of becoming a world-class AI Healthcare organization known for its Innovation, Compliance, and Compassion. Your primary responsibilities will include developing and implementing strategies for the clinical function at NIRAMAI, coordinating international and national clinical trials, and establishing a global network of Key-Opinion-Leaders to promote the adoption of innovative diagnostic solutions. You will also be tasked with ensuring compliance with healthcare regulations and standards, collaborating with various departments to design regulatory and marketing strategies, and organizing educational events to support brand marketing and business development. To excel in this role, you should possess a university degree in a relevant scientific discipline and have 7 to 15 years of experience in the pharmaceutical or medical devices industry. We are looking for a leader who can think creatively, build strong networks, and engage effectively with stakeholders and regulatory authorities. NIRAMAI Health Analytix Pvt Ltd is a health technology startup known for its Novel Cancer Detection Solution and commitment to enabling mass screening in both urban and rural areas. As a Series A funded company with a strong investor base, NIRAMAI has received numerous national and international awards, including being listed on CBInsights AI 100 2019 list. If you are passionate about making a difference in healthcare and have the expertise to lead a dynamic team focused on clinical research and regulatory compliance, we invite you to apply for the Clinical Research Scientist position at NIRAMAI Health Analytix.,

As the Director of Regulatory Research & Intelligence at Kamet Consulting Group, you will be responsible for leading and developing a team of research consultants in the life sciences and healthcare technology industry. Your role will involve overseeing regulatory intelligence, compliance support, and advisory services for clients in the pharmaceutical and medical device sectors. You will be the key authority for regulatory research activities in India, ensuring delivery excellence, quality control, and strategic insights. Your core responsibilities will include building and mentoring a team of research consultants, setting performance targets, and fostering their professional development. You will also be responsible for ensuring that all research, analysis, and regulatory intelligence meets global quality and compliance standards. Additionally, you will define and evolve the research agenda in alignment with regulatory trends and client priorities, oversee project delivery, and communicate complex regulatory insights to executive audiences. To qualify for this role, you should have an advanced degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field, with a preference for a PhD or MBA. You should have at least 10 years of experience in regulatory affairs, regulatory intelligence, or compliance within the pharma/medical devices industry, including 5 years in consulting and team management roles. Strong leadership skills, expert knowledge of global and Indian regulatory frameworks, exceptional communication abilities, project management experience, and an entrepreneurial mindset are essential for this position. Desired traits for the role include being well-read on regulatory and scientific literature, culturally adept in global teams, and having high ethical standards and a passion for quality in research and client service. Kamet Consulting Group offers a collaborative and innovative work environment, competitive compensation and benefits package, flexible working arrangements, and growth opportunities for all qualified applicants. Join us to contribute to meaningful technology in the life sciences domain and be part of a team committed to innovation.,

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions on regulatory topics, and ensuring the quality and compliance of critical documents/submissions related to DMFs, ANDAs/S, and Amendments. Furthermore, you will be responsible for formulating RA Strategy of ANDA/DMF/DS for ongoing projects, ensuring timely submissions to regulatory authorities, leading the Global DMF Team/Process, and coordinating global regulatory efforts for DMF/API between Raks, Amneal India & Amneal USA teams. Innovation and continuous improvement are key aspects of your responsibilities, as you will be developing RA tools, coordinating with SSSM team/vendors for document requirements, resolving DMF critical issues, and supporting audits with necessary regulatory information. Your role will also involve evaluating critical change notifications, supporting launch activities, handling team management and development, project distribution, resource planning, and candidate selection processes. Additionally, you will conduct yearly performance appraisals, approve team attendance, and ensure compliance with regulatory submissions. The ideal candidate for this role should have an M. Pharm / M. Sc. qualification and possess strong leadership skills, regulatory knowledge, and the ability to drive regulatory compliance across various projects and teams effectively.,

Position Overview: A Legal Manager is responsible for overseeing legal compliance, managing contracts, mitigating risks, and providing legal advice to the company. This role ensures that the organization's operations align with applicable laws and regulations while protecting its interests. Key Responsibilities: 1. Legal Compliance & Regulatory Affairs Ensure compliance with local, state, and national laws and regulations. Keep the company updated on changes in laws affecting business operations. Manage labour laws, environmental regulations, and industry-specific legal requirements. Handle licensing, permits, and statutory compliance. 2. Contract Management Draft, review, and negotiate contracts, agreements, and MoUs. Ensure contracts comply with legal and company policies. Address contractual disputes and mitigate legal risks. Maintain contract records and renewal timelines. 3. Litigation & Dispute Resolution Handle company litigation, arbitration, and dispute resolution. Liaise with external legal counsel for case management. Represent the company in legal proceedings when required. Prepare legal documents, responses, and defences. 4. Risk Management & Legal Advisory Identify legal risks and propose mitigation strategies. Advise management on corporate governance and legal matters. Conduct legal due diligence for mergers, acquisitions, and partnerships. Develop internal legal policies and guidelines. 5. Corporate & Labour Law Compliance Ensure adherence to labour laws, employment regulations, and industrial relations. Assist HR in handling employee grievances, disciplinary actions, and labour disputes. Oversee compliance with the Companies Act, taxation laws, and corporate governance. 6. Documentation & Record Keeping Maintain records of legal documents, agreements, and compliance reports. Ensure proper filing and retrieval of contracts, licenses, and legal notices. 7. Coordination & Stakeholder Management Collaborate with various departments to provide legal support. Engage with regulatory bodies, government agencies, and legal advisors. Conduct training sessions on legal and compliance matters for employees. Key Skills & Qualifications : Education & Experience: Bachelors or Masters degree in Law (LLB/LLM). 5-20 years of experience in corporate legal affairs, litigation, or contract management. Experience in infrastructure, construction, or real estate sectors (preferred). Technical & Soft Skills: Strong knowledge of corporate law, contract law, labour law, and regulatory compliance. Excellent drafting, negotiation, and analytical skills. Ability to handle litigation and manage external legal counsel. Strong communication, problem-solving, and decision-making skills. High ethical standards and attention to detail. Job Location: Corporate Office

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams Take your career farther than you thought possible, Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more careers bms /working-with-us , Upload health authority correspondence into BMS's RIM system including the required metadata, Create Health Authority queries in RIM and track to closure Ensures the correct keywords and submission/ correspondence linkages are established in RIM, Create Commitment records in RIM and send workflows/reminders to users on a regular basis Responsible for contacting users when data quality findings are identified and ensures issues are corrected, Create and distribute global CMC Change Controls and IMP Amendment events for commercial and investigational products Issue workflows in RIM to request assessments and submission planning Send reminders, as needed, and track the events to closure, Create and distribute global Labeling Change Control events Issue workflows to request assessments and submission planning Send reminders, as needed, and track the events to closure, Perform data quality checks on Labeling Events which drive reporting to the BMS Labeling Office Send routine reminders to local markets to correct labeling data quality findings identified through RIM reports Summarize and track issues, Create Investigator Brochure events in RIM and close out events as requested, Create Marketing and Investigational registrations and update as needed, based on information gathered through RIM reports, Work autonomously with local markets to troubleshoot and resolve issues Provide user support and address questions as needed, Prompt attention to business-critical activities to ensure compliance and appropriate documentation of regulatory approvals, Key Competency Requirements Proficient knowledge of global regulatory practices and regulatory operations Knowledge of regulatory information management and submission guidelines and requirements Knowledge of various types of health authority interactions, including HA correspondence, HA queries and HA commitments Experience and knowledge in regulatory information management software and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and technically skilled with such systems, Communicates questions and issues as they arise with possible solution Supports other functions as appropriate Effective written and verbal communication skills Works with supervision Ability to prioritize and strong attention to detail Experience instructing/ training end-users Experience in the development of work instructions and quick reference guides Communication and change management skills Educational Qualifications BA/BS degree, science / technology field preferred, Experience Requirements 4+ years pharmaceutical experience; 1+ year of regulatory operations experience , If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career, Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science?, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues, On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function, BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms Visit careers bms / eeo -accessibility to access our complete Equal Employment Opportunity statement, BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters, BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area, If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers bms /california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations, Show

Description Regulatory Associate (EU Market) Homebased Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Minimum 1 year of experience in Global Regulatory Affairs, Hands-on experience in the preparation and review of global CMC dossiers, variation applications, and post-approval changes, Solid understanding of regulatory markets and authorization dossier applications across regions including: EU, US, LATAM, APAC, Middle East, Africa, and China, Proven ability to work effectively in a fast-paced, team-oriented environment, Strong aptitude and attitude to learn and grow within the regulatory domain, Candidates with internship experience in Regulatory Affairs (CMC) will be given preference, Assists with preparation of product development documents including gap analyses and clinical development plans, Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorization transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines, Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests, Performs quality checks on related documents, Assists with submissions of other regulatory documents and other regulatory research as needed, Assists clients, customers, or others with general information Gathers, compiles, analyzes, and reports information, Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence, Qualification Requirements Masters in Pharmacy (Preferred)or Masters in science/healthcare field, or equivalent combination of education and experience, Excellent interpersonal / communication skills, Advanced skills in Microsoft Office Applications, Good time and project management skills, preferred, Strong analytical skills and attention to detail, Ability to work both as a team member and independently and to understand and carry out detailed instructions, Ability to interact with staff from multiple departments, Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred, Fluent in speaking, writing, and reading English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http:// syneoshealth Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show

Hiring for DRA Manager Location- Panchkula Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit Interested One share resume 9815675900

Experience in review and compile the registration and renewal dossiers as per Emerging markets. Review of master documents (PDP, PDR, AMV, MFR, MPR, Specifications, PVR, and Stability Protocols) and DMF. Experience of Handling post-approval changes for Emerging markets

To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA. To conduct or be part of team conducting risk assessment of various activities, equipment, systems, etc.. and responsible for assigning the QRM no. To review all labelling related artwork components for products. To prepare artwork information details for new / revised labelling components and submit to QA doc cell for issuance of artwork as per procedure. To review and verify the destruction of old printed packaging materials (vendor and Amneal site) in case of revision of artworks of labelling components. Tracking the actions, review of extensions, verification of documents and closure of actions. Responsible for document handling, issuance, distribution, and retrieval of document. Scanning of documents for regulatory submission To maintain master documents like Site Master File, Validation Master Plan, Quality Manual, SOPs, protocols, reports, Batch Records, specification, method of analysis, drawings, artworks, planners, etc.. Responsible for issuance, archival and retrieval of documents like SOPs, Validation / qualification protocols / reports, Batch records, Specifications, Drawings, Artworks, planners, etc.. To provide BMR/BPR numbering to exhibit, intended and media fill BMR. To provide Batch number to exhibit, commercial, feasibility and medial fill batches. To receive and distribute the product development documents like Master Formula Records, Master Packaging records, protocols (sampling, study, and stability protocols). Issuance of uncontrolled copy / reference copies of master document to user as and when requested by user. To provide requested documents to regulatory affairs department for regulatory submissions (AR or other submissions), whenever required. Artwork management that includes effective the Artwork information details, distribution, retrieval and archival of artwork and all labelling components. To retire the documents as per change control assessment / proposal. Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HODs instruction and guidance. Skills: Monitors production processes in real-time to ensure compliance with specifications and GMP, Batch record review, process monitoring, sampling, quality checks, real-time deviation management.

About The Role : Job TitleCorporate Trust - Debt & Agency, Analyst LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks 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. Trust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank 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. Summary: The Corporate Trust business is responsible for a broad portfolio of conventional debt and securitization transactions and service teams are required to engage directly with transaction parties supporting the administration of structured and non-structured debt issuances in accordance with the contractual terms. This role is exciting and broad rangingthe successful candidate will have extensive interaction across the transaction value chain and will be a critical component of the end to end service delivery to the client on a day to day basis ensuring all requirements are met in an accurate and timely manner. Duties will include processing client transactions and instructions, maintaining internal systems, producing reports in support of the front office to ensure the client receives the best possible service at all times. The successful candidate will be required to cover European working hours supporting the EMEA business Corporate title will depend on the relative experience of candidate. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Supporting the Corporate Trust EMEA business across a portfolio of products and services including Debt Capital Markets bonds and programme debt, liability management, project finance, asset repackaging vehicles and escrows Timely completion of client & deal management system records, for record keeping, document handling and revenue management - ensuring accuracy of data at all times Processing and settlement of deal related transactions - including account opening, payments, investments and securities settlements Interacting with deal parties including swap counterparties and investors as necessary Monitor and reconcile client ledgers, bank ledger, fee billing, late payment claims and other operational MIS break reports, providing regular feedback to client services management on all outstanding items Interact daily with operations teams to support all debt servicing requirements including query management and resolution Timely escalation of client or operational problems to team leaders / department head as relevant Supporting fellow team members, team leaders and department head on an ongoing basis Any other duties or ad-hoc projects as required Your skills and experience Relevant experience in a similar role in investment banking or corporate banking administration A good understanding of the global financial services industry, Fixed income and Debt Capital Markets Familiarity with debt capital markets transaction documentation is advantageous, but not essential A practical knowledge of banking operations and an understanding of SWIFT / payment processing Basic accounting knowledge and / or strong reconciliation skills Experience at interacting widely through a financial services organization The ability to work under pressure, handle multiple priorities and work as part of a team as well as individually Fluent written and spoken English is essential Additional European language skills including German, Spanish, Italian, French and Russian would be beneficial but not essential You will be: An effective and concise communicator, both verbal and written Numerate and analytical with strong attention to detail Able to interact with people from different business/disciplines acting consistently throughout the organization. A team player with strong communication skills, a proactive mind-set and a professional attitude to delivery and client-focus Able to work in a challenging and rapidly changing business environment Able to adapt to complex financial and operational matters PC literate with good working knowledge of Microsoft Office products particularly MS Excel. Parts of the role will be using internal systems for which training will be provided Educated to degree level or similar How well support you

About The Role : Job TitleRegulatory Reporting Associate LocationBangalore, India Role Description Regulatory Reporting is responsible for establishing and maintaining control frameworks designed to manage regulatory - monitoring, surveillance, compliance, transaction monitoring and screening. As a Regulatory Reporting team member, you will be responsible for managing daily reporting tasks and remediation activities. What well offer you , 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Participate in change and BAU activities. Perform daily reviews of exceptions within the SLAs. Ensure accurate investigation and timely escalations. Identify opportunities to create efficiency in the current process. Liaise with internal stakeholders for issue resolutions Participate in new system implementation and projects Review and update KOPs, SOPs etc. Keep track and maintain issue Jiras Prepare daily, weekly, and monthly MI. Your skills and experience Understanding of Transaction Reporting, Post Trade Reporting and Regulatory reporting framework Knowledge of Non-Financial Regulations. EMIR Refit & MiFID is a priority. Knowledge of Jira application Knowledge of Derivatives products Business Intelligence Skills (good to have) Alteryx, Tableau, SQL etc. Need to be aware and have and understanding of market, financial institutions, operations errors and risks. Must exhibit strong partnership skills. Team player, highly motivated, problem solver Inquisitive and analytical Strong communication skills Bachelors degree How well support you . . . .

About The Role : Job TitleRegulatory Control Analyst Corporate TitleAssociate LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as Anti Financial Crime) prevention. The Management and all employees are required to adhere to these standards to prevent DB and our reputation from those who may intend to use our products and services for money laundering, bribery, corruption, fraud and/or Terrorist Financing (TF) purposes. AFC KYC COE Implement a dedicated Centre(s) of Excellence for the AFC element of the KYC file review, allowing customers to be reviewed once in review cycle. Below are some of the key principals . Achieve economies of scale through the creation of one functional team with sophisticated risk managers, under one global leader who is accountable for the AFC KYC file review and sign-off process. Ensure fulfilment of local regulations and regulatory expectations in an efficient, risk focused manner. Ensure sufficient resources to create and effectively maintain a follow the sun KYC file review aligned with ACO availability. Seek opportunities to geographically co-locate the CoE with respective 1LoD counterparties (i.e. align with the 1LoD Target Operating Model) to stimulate cooperation and strengthen the relationship What well offer you , 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Review and approve client escalations for Remediation, Regular Review, New Product Extensions and Event Driven Reviews within the agreedSLAs Ensure the generated client risk rating is in line withexpectations & procedures. Assess the risk factors identified through the due diligence provided by client lifecycle management (CLM) Apply subject matter expertise judgment as to relevance and/or materiality of Escalation triggers; i.e., can the overall assessment bedefended Engage with appropriate BLAFC specialist team where further escalation is required e.g., local BLAFC, AFBC, Sanctions, BIUetc.. Liaise with CLM to obtain additional information or request ACO to conduct additional research whererequired Ensure outcome and rational is clearly documented within the KYC systems and / or escalated for furtherguidance Ensure that KYC reviews undertaken are in line with the KOPs guidelines andprocesses Contributing to the wider globalKYCCentre of Excellence programme, identifying best practices Deciding on new or existing clients that are escalated or deciding to escalate further to Governance Forums for review. Defining and implementing strategic TOM in-line with local/regional/global standards and change programmes. Your skills and experience Skills: Ability to identify and manage financial crime risks arising from regular reviews, event driven reviews, new client adoptions and new productextensions Strong communication, organizational, and interpersonal skills with the confidence to engage and advise professionally and persuasively with stakeholders. Proven analytical skills, problem solving ability, and a control mindset paired with meticulous attention to detail. Able to raise sensitive or potentially contentious issues in a constructive manner to reach appropriate solutions. driven with the ability to multi-task and work in a fast-paced environment. Ability to handle time-sensitive projects while focusing on the quality of work delivered. Self-motivated and proactive team player who takes ownership of assignments, thrives in a teamwork-oriented environment, and works well under pressure. Ability to work with various stakeholders across all 1LoD and 2Lod and manage expectations, without impacting the quality output. Experience: Must be a graduate with any stream with at least 4-5 years experience in AFC or a related control related function within an international organization/bank in the Financial Services industry with extensive experience with the KYC process. People having a degree or diploma in AML/KYC will be preferred. A strong track record in risk and regulatory matters, ideally including: Good understanding of AFC risks and typologies in order to identify areas or instances of potential AFC risks and to address them appropriately. Experience of relevant regulations/laws and related circulars Financial Crime function expertise and should be considered a Subject Matter Expert (SME) in the Financial Crime area on relevant laws and regulations. Should be flexible with respect to work timings. Should be comfortable in working on MS Office tools using word and excel. How well support you . . . . About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Qualification: M.Sc. / M.Pharm / Ph.D. in Life Sciences, Biomedical Sciences, Biotechnology, or a related field Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist with strong experience in medical and clinical writing, focused on regulatory compliance under EU IVDR. The ideal candidate will have hands-on expertise in authoring key performance evaluation documents and supporting the preparation and maintenance of Technical Documentation (TD) for CE marking of IVD products. In addition to EU IVDR compliance, the candidate will support global product registration efforts , including preparation of regulatory documentation for submission in multiple markets. The role requires collaboration with cross-functional teams to ensure timely and accurate preparation of regulatory documents , risk files, and performance data packages for international regulatory approvals. Familiarity with immunoassays, including ELISA and fluorescence-based methods, particularly for infectious disease diagnostics, is preferred. Key Responsibilities: 1. Performance Evaluation Documentation: Author and maintain IVDR-mandated performance evaluation documents, including: Scientific Validity Reports (SVRs) Analytical Performance Reports (APRs) Clinical Performance Reports (CPRs) Performance Evaluation Reports (PERs) Ensure alignment with EU IVDR Annex XIII, MDCG guidelines, and ISO standards. Compile and interpret data from internal validations, clinical studies, and external literature. Coordinate with laboratory/R&D teams to ensure appropriate data generation for APRs and CPRs. 2. Scientific Validity & Literature Review: Conduct systematic literature searches using PubMed, Embase, Scopus, and other databases. Define and document search strategies, selection criteria, and appraisal methodology. Evaluate and synthesize scientific evidence supporting biomarkercondition associations. Develop literature matrices, evidence tables, and justification summaries for SVRs. 3. Regulatory Documentation & Global Registration Support: Prepare and maintain CE Technical Files/Design Dossiers and ensure alignment with GSPRs. Support global product registration activities by preparing and submitting regulatory documentation as per country-specific requirements. Ensure timely preparation and submission of documents for new market approvals and renewals. Assist in regulatory gap assessments and remediation planning for international markets. Contribute to Risk Management Files (ISO 14971) and Post-Market Performance Follow-up (PMPF) documentation. 4. Cross-Functional Coordination & Audit Support: Collaborate with RA, QA, R&D, PMS, and manufacturing teams for data collection and alignment. Participate in internal audits and assist with responses to Notified Body and regulatory authority observations. Support vigilance reporting and post-market analysis through literature and performance data review. Required Skills & Experience: 5-7 years of experience in regulatory affairs and clinical/performance documentation for IVDs or medical devices. In-depth knowledge of EU IVDR, ISO 13485, ISO 20916, CLSI guidelines, and applicable international regulatory standards. Proven experience in preparing performance evaluation documents and conducting systematic literature reviews. Strong understanding of immunoassay technologies and infectious disease diagnostics. Excellent documentation, data analysis, and regulatory writing skills.

Job Purpose and Impact The Business Analyst - HR Core will lead efforts through influence that will enable change in an organizational context through the creation of the definition of the business needs and the creation of solution recommendations that deliver value to stakeholders. In this role, you will use advanced knowledge of the tasks and techniques that are used to perform complex business analysis such as solution evaluation, strategy analysis, elicitation and collaboration, requirement life cycle management, requirements analysis and design definitions and business analysis planning and monitoring to advance the profitability or efficiency of the business. You will partner effectively with all levels of the organization, guide others, drive results, proactively identify and resolve problems and make challenging decisions to improve business performance. Key Accountabilities Facilitate requirements gathering sessions with business stakeholders, document requirements and create initiatives that support the business requirements and needs. Identify and effectively articulate the need for change in how the organization works and facilitate change applying change management methodologies. Identify and define the solutions to complex business problems that will maximize the value delivered to stakeholders. Guide the business through unknown or unmapped territory to advance to the desired destination as the liaison to cross functional, regional and global solutions delivery teams. Use a thorough comprehension of complex internal or external business issues to analyze the organization or business domain and document business, data, processes or systems and provide an assessment of the business model and the integration with technology. Create test scripts using a traceability matrix tied back to requirements and assist in management of user acceptance testing cycles. Collaborate across all levels of the organization to collect information about an organizations operations to improve systems and processes, research business processes, analyze the potential impact and create and effectively communicate recommendations for the leadership team. Independently handle complex issues with minimal supervision, while escalating only the most complex issues to appropriate staff. Partner to evolve the capability associated with the process and technology, identify opportunities to optimize processes for improved user experience and conduct regular reviews of standards and success measures. Qualifications MINIMUM QUALIFICATIONS: Bachelors degree in a related field or equivalent experience. Minimum of four years of related work experience. Other minimum qualifications may apply. PREFERRED QUALIFICATIONS: 3+ years experience in SuccessFactors Employee Central (any other modules a plus). Experience in Human Resources with core processes. Certified Six Sigma (green / yellow belt) and / or Kaizen. Identify and define solutions to moderately complex business problems that will maximize the value delivered to stakeholders. Support implementation of the operating model of a domain process by collaborating closely with human resources leaders to drive continuous improvement across the assigned domain. Support implementation of programs to build process and technology capability, identify opportunities to optimize processes for improved user experience and participate in regular reviews of standards and success measures.

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug saftey associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety AssociateDrug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

About the Role: Leap Scholar is a one-stop platform for any aspirant wishing to study abroad. It is a transaction platform for students to apply to the university of choice. The charter for this role will include: Conduct online telephonic and/or virtual counselling sessions with students interested in studying abroad Guide students on what courses to opt for based on their profile and interest Assist students on deciding on the universities/colleges and programs to opt for Assist in preparing and filing of their applications Guiding students on the visa process and visa applications Participate in educational activities such as exhibitions and events as and when required Ideal Persona would : 1+ years of experience in counselling students on admissions to universities and colleges in the UK, USA, Canada, Australia, Germany, NZ, Europe. Understanding of various courses and career options across various disciplines Experience of guiding students on the best course option based on the students profile and career interests Sound understanding of the admission process for Diploma, Bachelors, Post-Graduation diploma, and Masters degrees in the USA, UK, or Canada. If you have the skills and experience required for this position and are passionate about international education, we encourage you to apply.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Contract Management Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations, and integrations, and can guide others in leveraging it effectively. Must have skills:3+ years of Cobblestone or similar Conract life cycle management tool hands on experience High analytical skills to understand and implement the requirementsGood communication and ability to handle client and cross team communications independently and effectively Ability to create meaningful requirement and status documentation in client specific formatFunctional testing knowledge Good to have:Certification in cobblestone or IcertisHealthcare Domain knowledge Qualification 15 years full time education