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6.0 - 9.0 years
7 - 8 Lacs
ahmedabad
Work from Office
Prepare and compile DMF/ANDA Drug Substance modules (especially Module 2 & 3) in compliance with regulatory requirements. Review DMF submissions and respond to regulatory deficiencies and queries in a timely and accurate manner. Coordinate with internal teams (R&D, QA/QC, Manufacturing) and external stakeholders to gather and validate required documentation. Ensure alignment with FDA and ICH guidelines throughout the submission lifecycle. Monitor regulatory updates and proactively implement changes in submission strategy. Maintain regulatory documentation and track submission timelines and approvals. Participate in audits and inspections, providing regulatory support and documentation as needed. Required Skills: DMF/ANDA Drug Substance Module Preparation | Expert DMF Review & Deficiency Response | Advanced FDA & ICH Guidelines | Expert Regulatory Documentation & Submission Systems | Advanced
Posted -1 days ago
11.0 - 16.0 years
16 - 18 Lacs
ahmedabad
Work from Office
IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both
Posted -1 days ago
4.0 - 8.0 years
5 - 15 Lacs
greater noida
Hybrid
For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination :- Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements Reporting & Maintenance :- Maintain regulatory files/database
Posted Just now
10.0 - 14.0 years
5 - 9 Lacs
gurugram, bengaluru
Work from Office
Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ITIL Foundation Certification in IT Service Management Responsibilities Your Qualifications: The candidate should have 12+ years of IT experience which includes Service Delivery Management experience and have a track record in collaborating with large-scale global teams. High commitment with his/her customers is must. The role will be based out of Bangalore/NCR/Mumbai Your Responsibilities Key tasks include, but are not limited to, the following: SCOPE: Manage service delivery activities for customers Oracle Cloud Infrastructure setup Represent as a single point of contact between customer & Oracle. Manage the service delivery through virtual team of resources from multiple XLOBs Establish priorities & Service growth plans for customers aligned to Oracles Cloud Strategy. ACCOUNTABILITIES Customer handover from Service Desk & Customer Introduction Schedule & Deliver Service Kickoff with Customer & Internal Stakeholders Prepare the Joint Contact & Escalation Guide (JC&EG) Request for Cloud Delivery Architect (CDA) to be assigned for Discovery of customer environment in OCI CSS Problem Management Notification Customer Information Setup in Fusion CX (Internal tool) Digital Learning My Learn Admin Account Setup RESPONSIBILITIES Prepare & deliver Monthly Service Reviews to customer Monthly Incident Analysis Reports Trend Analysis & Status of Remediation Deliver Quarterly SVRs Act as Incident Communicator during Major Incidents Join/Co-host External War Room with Service Desk and customer Responsible for sharing RCA with customer & Remediation follow-up Responsible to track & Report Digital Learning Consumption in OCI Analyze OCI cost consumption data and report findings to customer Coordinate with XLOBs during any Major incidents to drive incident resolution Issue and Risk Management Escalation Management Technical Expertise: Oracle Cloud Infrastructure Knowledge: Proficient in Oracle Cloud Infrastructure. Experienced in ExaCS. Knowhow of OCI network architecture Tech Skills: MAA, Disaster Recovery, Security, Backups, Compliance, Capacity Planning Oracle Cloud Certification: Foundation, Associate Architect Soft Skills: Able to consider diverse perspectives Ability to articulate and translate customer needs into solutions. Demonstrates creativity and innovativeness. Stakeholder management: Strong ability to manage stakeholders effectively. Customer management: Strong ability to manage customer expectations Excellent communication abilities Ability to communicate with virtual XLOB team(s) Ability to lead and drive technical discussions related to Oracle Cloud Infrastructure
Posted 1 hour ago
1.0 - 6.0 years
20 - 35 Lacs
mumbai
Work from Office
SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and Nature) Hands-on exposure to asset tracking systems, advanced MS Office, or asset management tools . Experience in monitoring, recording, and reconciling fixed assets . Practical experience in coordinating with procurement, finance, and operations teams for asset lifecycle management. Experience in asset management, inventory control, or finance-related roles . Technical competency and skill required to execute the role Proficiency in asset tracking, tagging, and lifecycle management . Ability to maintain and reconcile asset registers, depreciation schedules, and disposal records . Familiarity with advanced MS Office (Excel, Word, PowerPoint) . Competence in variance analysis, MIS reporting, and asset reconciliation . Ability to prepare asset utilization and cost-benefit analysis reports . Ability to generate dashboards and reports for management decision-making . Knowledge of inventory control methods .
Posted 2 days ago
3.0 - 11.0 years
7 - 8 Lacs
pune
Work from Office
Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.
Posted 2 days ago
1.0 - 3.0 years
3 - 5 Lacs
vadodara
Work from Office
Job Title: Executive FRD Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location: Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form (Implant, In-situ-gel, etc. ) based on QbD approach. To execute the experiments as per Design of experiments To do literature search, prepare summary report and review for ANDA projects. To prepare product development study protocols and reports as per regulatory requirements. To enter the experimental details, observations and test request in the eLNB/METIS software. Experimental trials and stability study results compilation and interpretation using MINITAB software. To prepare Technology Transfer documents like MF, Risk Assessment based upon CPP & CQA, To prepare justification for import material, documents for form 29 application and Common Pharmaceutical Document for DCGI submission. To execute scale up / exhibit batches at plant and prepare scale up summary report To prepare Stability protocol as per regulatory requirement. To prepare Product Development Report, Risk assessment report for Elemental impurities, Residual solvents and Extractable for regulatory submission. To prepare pre-ANDA meeting package, scientific justification and /or report for various regulatory agency To prepare SOPs related to laboratory equipment / instrument. To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents. To comply with the internal quality system while performing any activity. To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity. Travel Estimate NA Job Requirements Educational Qualification M. Pharm Experience Tenure : 1-3 years Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together!
Posted 3 days ago
6.0 - 8.0 years
8 - 10 Lacs
vadodara
Work from Office
. Job Title: Senior Executive /Manager 2 = Formulation Development Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G11B / G11A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Description Experience in end-to-end topical product, parenteral product (injection) product development activities for generic product development ANDA (Cream, ointment, gel, solution, lotion, foam, patch, solution injection, depo injection, prefilled syringe, cartridge based injection etc. ) as well as NDA 505(b)(2) and 505(b)(1). Experience in execution of lab scale manufacturing, reverse engineering, analytical know-how, plant level manufacturing activities; scale-up and exhibit batches based on quality principles QbD, QTPP, CQA, CMA, CPP, RA, FMEA. Experienced scientist to perform experiments for development of optimum prototypes (generic, non-infringing composition and robust manufacturing process) with diverse class of drugs & prodrugs (sensitive to pH, acid, base, temperature, oxygen, humidity). Experience in regulatory documentation CMC, MF, BMR, PDR, controlled correspondence for CMC, Biowaiver & Dossier preparation for US-FDA, EU-EMA, AU-TGA & DCGI through successful filing. Experience in working with cross-functional teams (ADD, MSTG, production, QC, QA, RA, IPC, PMO, BD, Microbiology, Pharmacology etc. ) to achieve project goals - Filings and subsequent approvals. Knowledge and develop continuous understanding on competitive intelligence, due diligence, US-FDA quality concepts, statistics and global pharma trend analysis to support new product evaluation & introduction Travel Estimate NA Job Requirements Educational Qualification M. Pharm or PhD Experience Tenure : 6 to 8 years if M. {harm or 3. 5 years if PhD Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
Posted 3 days ago
0.0 - 5.0 years
4 - 9 Lacs
bengaluru
Work from Office
Your Day-to-Day Tasks Include: 1. Initiating first level contact with Inbound and Outreach leads. 2. Creating and executing an outreach strategy in collaboration with the PDR Managers and PDR team leads.
Posted 3 days ago
3.0 - 6.0 years
2 - 7 Lacs
bharuch
Work from Office
R&D (Synthesis) -Agrochemical Industry-Saykha,Gujarat. Capital Placement Services Industry IT Software - Application Programming / Maintenance Qualification M.Sc Key Skills Green Field Projects UPLC Gujarat R&D (Synthesis) PDR R&D Develo
Posted 3 days ago
4.0 - 8.0 years
5 - 15 Lacs
greater noida
Hybrid
For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination :- Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements Reporting & Maintenance :- Maintain regulatory files/database
Posted 4 days ago
12.0 - 14.0 years
11 - 16 Lacs
pune
Work from Office
Job profile Qualification : Bachelors Degree / Master Degree Industry Type : FM Services, Hotels, Projects, Overall Experience : 12 -14 years Industry Experience : 10-12 years of relevant / equivalent experience Technical Skills : Building Services Generic Skills : Leadership, Communication, Vendor/people management, Strategies Behaviors : Team work, Learning attitude, Innovation mindset Job Aim: To take complete ownership for all client deliverables for all the facilities in the city. The person will be responsible to provide comprehensive facility management services, as per the contractual terms with a focus on continuous improvement for the respective facilities. Will also be responsible to achieve financial and other Key Performance Indicators ( KPIs) established by the Client. The Regional Head must be a team player and work with other functions within JLL and also the client stakeholders to achieve outcomes. Competencies Interpersonal skills with a strong client focus. Team Leader with line management skills and the ability to delegate Client /Supplier relationship management Technical comprehension and experience with performance based service contracts and vendor management Knowledge of occupational safety requirements Strong budget management and financial analysis skills Excellent written and oral communication skills. Strong analytical skills. Responsibilities Operations delivery Overall service delivery of the region KPI / Compliance Scores and management Manage escalations with closure in a timely manner People Management Ensure right expectation setting for the team, ability to maximise performance of the team. Training for the team Growth Plan for the team Employee assessment, identify shortcomings and plan development Technology Ensure optimum utilization of all technology tools that are implemented from time to time. Innovation/ Initiative Keep a track and updates on Energy savings project for the region. Focus / Thrust on improvements/ initiatives Financial Acumen Keep a track one Office services / R&M /Capex Budgets /work closure Understanding of the facility / City spend Track FM Operational Expenses CRM / SRM Client/employee engagement, Leadership connects Service partners engagement Vendor management Vendor engagement /Identification and evaluation on larger aspects Expansion/Go live Overall planning / Cost proposal & approval Approval/transition/Go live Ensure/oversee closure on project snag BCP /Risk management Oversee, assess risk, plan and handle any BCP situation. Certification/Internal Audit Ensure/oversee preparation end to end for all audits Business Reviews Responsible for Quarterly Business Reviews Publish timely and relevant reports for client and senior management
Posted 4 days ago
12.0 - 14.0 years
11 - 16 Lacs
bengaluru
Work from Office
Job profile Qualification : Bachelors Degree / Master Degree Industry Type : FM Services, Hotels, Projects, Overall Experience : 12 -14 years Industry Experience : 10-12 years of relevant / equivalent experience Technical Skills : Building Services Generic Skills : Leadership, Communication, Vendor/people management, Strategies Behaviors : Team work, Learning attitude, Innovation mindset Job Aim: To take complete ownership for all client deliverables for all the facilities in the city. The person will be responsible to provide comprehensive facility management services, as per the contractual terms with a focus on continuous improvement for the respective facilities. Will also be responsible to achieve financial and other Key Performance Indicators ( KPIs) established by the Client. The Regional Head must be a team player and work with other functions within JLL and also the client stakeholders to achieve outcomes. Competencies Interpersonal skills with a strong client focus. Team Leader with line management skills and the ability to delegate Client /Supplier relationship management Technical comprehension and experience with performance based service contracts and vendor management Knowledge of occupational safety requirements Strong budget management and financial analysis skills Excellent written and oral communication skills. Strong analytical skills. Responsibilities Operations delivery Overall service delivery of the region KPI / Compliance Scores and management Manage escalations with closure in a timely manner People Management Ensure right expectation setting for the team, ability to maximise performance of the team. Training for the team Growth Plan for the team Employee assessment, identify shortcomings and plan development Technology Ensure optimum utilization of all technology tools that are implemented from time to time. Innovation/ Initiative Keep a track and updates on Energy savings project for the region. Focus / Thrust on improvements/ initiatives Financial Acumen Keep a track one Office services / R&M /Capex Budgets /work closure Understanding of the facility / City spend Track FM Operational Expenses CRM / SRM Client/employee engagement, Leadership connects Service partners engagement Vendor management Vendor engagement /Identification and evaluation on larger aspects Expansion/Go live Overall planning / Cost proposal & approval Approval/transition/Go live Ensure/oversee closure on project snag BCP /Risk management Oversee, assess risk, plan and handle any BCP situation. Certification/Internal Audit Ensure/oversee preparation end to end for all audits Business Reviews Responsible for Quarterly Business Reviews Publish timely and relevant reports for client and senior management
Posted 4 days ago
0.0 - 4.0 years
2 - 6 Lacs
vadodara
Work from Office
About Us : Established in 1991, Matrix (www.matrixcomsec.com) is a leader in Security and Telecom solutions for modern businesses and enterprises. Matrix has launched cutting-edge products like Video Surveillance Systems - Video Management Software, Network Video Recorder, and IP Camera, Access Control and Time-Attendance Systems as well as Telecom Solutions such as Unified Communications, IP-PBX, Universal Gateways, VoIP and GSM Gateways, and Communication Endpoints. These solutions are feature-rich, reliable, and conform to international standards. Having global footprints in Asia, Europe, North America, South America, and Africa through an extensive network of more than 2,500 channel partners, Matrix ensures that the products serve the needs of its customers faster and longer. We aspire to be the world leader in innovative telecom and security solutions by offering cutting-edge, high-performance telecom and security solutions to business customers. Roles and Responsibilities : Maintain client relations to build excellent reputation for service and produce repeat business. Interact regularly with top ten accounts related to weekly selling, deliveries and stock availability. Maintaining contact with existing clients to ensure that they are satisfied with their services Building relationships with existing clients to ensure repeat business and new business opportunities Managing existing customer accounts by ensuring that existing customers remain satisfied with company products and services. Developing and implementing effective account plans to retain existing customers. Identifying customer needs and communicating how company products and services fulfill those needs. Suggesting innovative ways to increase sales and enhance clients' experience. KRA's: Sales from regular SI's Number of SI's build How to get constant business from SI's Skills Required: Ability to increase customer engagement. Knowledge of customer relations management software and MS Office. Outstanding communication and negotiation skills. Analytical and time management skills.
Posted 4 days ago
7.0 - 11.0 years
11 - 16 Lacs
mohali
Work from Office
Regional Head – Operations Job type : Full time Reporting Manager : India Operations Director / Account Director No of staff managed : 200 Job profile Qualification Bachelor’s Degree / Master Degree Industry Type FM Services, Hotels, Projects, Overall Experience : 12 -14 years Industry Experience 10-12 years of relevant / equivalent experience Technical Skills Building Services Generic Skills Leadership, Communication, Vendor/people management, Strategies Behaviors Team work, Learning attitude, Innovation mindset Job Aim: To take complete ownership for all client deliverables for all the facilities in the city. The person will be responsible to provide comprehensive facility management services, as per the contractual terms with a focus on continuous improvement for the respective facilities. Will also be responsible to achieve financial and other Key Performance Indicators ( KPIs) established by the Client. The Regional Head must be a team player and work with other functions within JLL and also the client stakeholders to achieve outcomes. Competencies Interpersonal skills with a strong client focus. Team Leader with line management skills and the ability to delegate Client /Supplier relationship management Technical comprehension and experience with performance based service contracts and vendor management Knowledge of occupational safety requirements Strong budget management and financial analysis skills Excellent written and oral communication skills. Strong analytical skills. Responsibilities Operations delivery Overall service delivery of the region KPI / Compliance Scores and management Manage escalations with closure in a timely manner People Management Ensure right expectation setting for the team, ability to maximise performance of the team. Training for the team Growth Plan for the team Employee assessment, identify shortcomings and plan development Technology Ensure optimum utilization of all technology tools that are implemented from time to time. Innovation/ Initiative Keep a track and updates on Energy savings project for the region. Focus / Thrust on improvements/ initiatives Financial Acumen Keep a track one Office services / R&M /Capex Budgets /work closure Understanding of the facility / City spend Track FM Operational Expenses CRM / SRM Client/employee engagement, Leadership connects Service partner’s engagement Vendor management Vendor engagement /Identification and evaluation on larger aspects Expansion/Go live Overall planning / Cost proposal & approval Approval/transition/Go live Ensure/oversee closure on project snag BCP /Risk management Oversee, assess risk, plan and handle any BCP situation. Certification/Internal Audit Ensure/oversee preparation end to end for all audits Business Reviews Responsible for Quarterly Business Reviews Publish timely and relevant reports for client and senior management Location On-site –Bengaluru, KA Scheduled Weekly Hours: 40 If this job description resonates with you, we encourage you to apply even if you don’t meet all of the requirements. We’re interested in getting to know you and what you bring to the table! JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL’s recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. Candidate Privacy Statement . For candidates in the United States, please see a full copy of our Equal Employment Opportunity and Affirmative Action policy here. Jones Lang LaSalle (“JLL”) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process – including the online application and/or overall selection process – you may contact us at Accommodation Requests . This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page I want to work for JLL.
Posted 4 days ago
7.0 - 11.0 years
11 - 16 Lacs
bengaluru
Work from Office
Regional Head – Operations Job type : Full time Reporting Manager : India Operations Director / Account Director No of staff managed : 200 Job profile Qualification Bachelor’s Degree / Master Degree Industry Type FM Services, Hotels, Projects, Overall Experience : 12 -14 years Industry Experience 10-12 years of relevant / equivalent experience Technical Skills Building Services Generic Skills Leadership, Communication, Vendor/people management, Strategies Behaviors Team work, Learning attitude, Innovation mindset Job Aim: To take complete ownership for all client deliverables for all the facilities in the city. The person will be responsible to provide comprehensive facility management services, as per the contractual terms with a focus on continuous improvement for the respective facilities. Will also be responsible to achieve financial and other Key Performance Indicators ( KPIs) established by the Client. The Regional Head must be a team player and work with other functions within JLL and also the client stakeholders to achieve outcomes. Competencies Interpersonal skills with a strong client focus. Team Leader with line management skills and the ability to delegate Client /Supplier relationship management Technical comprehension and experience with performance based service contracts and vendor management Knowledge of occupational safety requirements Strong budget management and financial analysis skills Excellent written and oral communication skills. Strong analytical skills. Responsibilities Operations delivery Overall service delivery of the region KPI / Compliance Scores and management Manage escalations with closure in a timely manner People Management Ensure right expectation setting for the team, ability to maximise performance of the team. Training for the team Growth Plan for the team Employee assessment, identify shortcomings and plan development Technology Ensure optimum utilization of all technology tools that are implemented from time to time. Innovation/ Initiative Keep a track and updates on Energy savings project for the region. Focus / Thrust on improvements/ initiatives Financial Acumen Keep a track one Office services / R&M /Capex Budgets /work closure Understanding of the facility / City spend Track FM Operational Expenses CRM / SRM Client/employee engagement, Leadership connects Service partner’s engagement Vendor management Vendor engagement /Identification and evaluation on larger aspects Expansion/Go live Overall planning / Cost proposal & approval Approval/transition/Go live Ensure/oversee closure on project snag BCP /Risk management Oversee, assess risk, plan and handle any BCP situation. Certification/Internal Audit Ensure/oversee preparation end to end for all audits Business Reviews Responsible for Quarterly Business Reviews Publish timely and relevant reports for client and senior management Location On-site –Bengaluru, KA Scheduled Weekly Hours: 40 If this job description resonates with you, we encourage you to apply even if you don’t meet all of the requirements. We’re interested in getting to know you and what you bring to the table! JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL’s recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. Candidate Privacy Statement . For candidates in the United States, please see a full copy of our Equal Employment Opportunity and Affirmative Action policy here. Jones Lang LaSalle (“JLL”) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process – including the online application and/or overall selection process – you may contact us at Accommodation Requests . This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page I want to work for JLL.
Posted 4 days ago
5.0 - 8.0 years
5 - 9 Lacs
bengaluru
Work from Office
About The Role Skill required: Talent Acquisition - Onboarding Designation: Talent Connector Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsCandidates with End to End Recruitment experience - Domestic/International MarketAdminister onboarding of new employees including all onboarding activities like orientation registration, completion of background check, creation of SAP record, etc. What are we looking for? ATS/ Job boards/ HCMUS/Canada recruitment Experience is a Must have" Excellent communication skills, Uses professional, error-free grammar and formatting in emails Speaks with clarity, warmth, and confidence during virtual interactions." Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shiftsShould have hands on experience in US boarding and aware of the legalities regarding onboarding of the candidates.Recruitment Onboarding will be responsible for performing day to day task as per the recruitment process guidelines:1. Perform pre-employment checks & New Joiner On boarding.2. Handhold candidates during the Pre-employment checks process3. Coordinate with BGC / Drug test vendors for Coordingation of backgroundchecks4. Should ensure that candidate is 100% compliant as per the client requirements before he joins5. Follow up with candidates and vendors to ensure the candiates BGC/ drugtest are completed on time6. updation of the HCM/ onboarding system with BGC updates or anychanges in the DOJ or any thing related to candidates.7. Ensuring all the recruiters and hiring managers are update to their respective candidates8. resovling candidate queries regarding onboaridng process9. Reporting on onboaridng issue and challenges Qualification Any Graduation
Posted 4 days ago
6.0 - 13.0 years
8 - 15 Lacs
bengaluru
Work from Office
JOB DESCRIPTION Job Title: Junior Manager - Regulatory Affairs Job Location: Syngene International Limited, Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND) About Syngene : Syngene ( www. syngeneintl. com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: The candidate will combine his/her knowledge of scientific & regulatory guidelines, CMC regulatory and filing skills to ensure successful filing, registrations, and post-approval maintenance for the intended countries. The candidate will lead eCTD filing, Regulatory DMS and QMS system activities. Role Accountabilities The candidate s contribution will help bring the much-needed therapeutics to the unmet need of the patients, thereby positively impacting mankind. The candidate will be accountable for: Pivotal CMC Regulatory support throughout the development cycle of the novel drugs space and generics space, including small molecule & biologics, in marketing authorization / DMF filing and lifecycle management, predominantly for Developed countries and for certain Emerging countries, based on the market requirement. Research on regulatory requirements for new molecules / category of products based on business need in time-bound manner and provide feasibility/technical inputs to the team. Identify requirements for IND, NDA, MAA, ANDA, ANADA and other Dossiers, prepare checklists, ensuring regulatory compliance. Interact with stakeholders, collate necessary document, Review plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc, conduct thorough regulatory assessment, identify risks, communicate to team and client, and recommend corrective measures. Plan and develop sections, compile, author, and Publish eCTD Dossiers. Ensure timely submission. Respond to regulatory agencies on a timely basis. Responsible for Regulatory project management. Provide Regulatory strategy inputs to the team and the clients. Assessing the regulatory requirements for various business requirements as and when needed. Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers/DMFs as required to meet changes in internal systems, changes in regulatory guidelines. Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists, and review New Quality Agreements. Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted by the company. Traveling to other sites within Karnataka if necessary, though travel requirements are minimal. Leadership Capabilities Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience Must have experience of 6 to 13 years in CMC Regulatory Affairs for small molecule API / Formulations (preferably in injectables) for US/Europe/Developed Markets Must have hands-on experience in investigational medicinal products and marketing authorization. Experience in Biologicals /ADC / veterinary drugs is a definite plus. Skills and Capabilities High-level English Proficiency in reading, writing, and communication Hands-on Experience in eCTD. Experience in RDMS, EDMS & QMS is definite plus. Thorough understanding of CMC (API & Drug Product) and skill in regulatory interpretations and application Education B. Pharm / M. Pharm / Life sciences degree with minimum 5 + years of working experience with Pharmaceutical / Life science. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities
Posted 4 days ago
2.0 - 5.0 years
3 - 7 Lacs
navi mumbai
Work from Office
Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficiency responses and/or post-approval submissions for above markets. Worked on various dosage forms including complex generics. Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections. Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections. Hands on experiance for ECTD compilation. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Masters Graduation in Pharmacy or Science
Posted 5 days ago
2.0 - 5.0 years
5 - 9 Lacs
noida
Work from Office
About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Oracle Utilities Customer to Meter C2M SPL Good to have skills : NA Minimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications function seamlessly to support organizational goals. You will also participate in testing and troubleshooting to enhance application performance and user experience, contributing to the overall success of the projects you are involved in. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Assist in the documentation of application processes and workflows.- Engage in continuous learning to stay updated with industry trends and technologies. Professional & Technical Skills: - Must To Have Skills: Proficiency in Oracle Utilities Customer to Meter C2M SPL.- Strong analytical and problem-solving skills.- Experience with application development methodologies.- Familiarity with database management and SQL.- Ability to work collaboratively in a team environment. Additional Information:- The candidate should have minimum 2 years of experience in Oracle Utilities Customer to Meter C2M SPL.- This position is based at our Noida office.- A 15 years full time education is required. Qualification 15 years full time education
Posted 6 days ago
12.0 - 17.0 years
10 - 20 Lacs
hyderabad
Work from Office
Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Minimum Qualifications: Bachelor's degree. 6+ years of Finance, Accounting, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions
Posted 6 days ago
5.0 - 8.0 years
10 - 14 Lacs
hyderabad
Work from Office
About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Asset Management Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that the applications are aligned with business objectives and user needs, while maintaining a focus on quality and efficiency throughout the project lifecycle. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of milestones. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP Asset Management.- Good To Have Skills: Experience with SAP S/4HANA.- Strong understanding of application lifecycle management.- Experience in integrating SAP Asset Management with other enterprise systems.- Familiarity with agile methodologies and project management tools. Additional Information:- The candidate should have minimum 5 years of experience in SAP Asset Management.- This position is based at our Hyderabad office.- A 15 years full time education is required. Qualification 15 years full time education
Posted 6 days ago
4.0 - 9.0 years
12 - 16 Lacs
gurugram
Work from Office
About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbeing needs of our people while helping make their working life experience more rewarding. Whats in it for you To grow with a global company and learn more about key global benefits initiatives around the world. S&P Global puts our people first, and you will have the opportunity to participate in making positive change through global programs such as Wellbeing Reimbursement, Global Education, Global Parental Leave, Flexible Time Off program, Global EAP, Insured and Retirement benefits in the EMEA region. Responsibilities Manage benefits administration, renewals and day-to-day operations Support benefits programs involving the research and implementation of plans and programs as well as managing competitive benefits offered in the APAC region Subject matter expert for all benefits queries and escalations while also providing guidance and support to various business units Work closely with the external vendors, local leadership of the respective countries, HR partners, and other functions to offer best in class benefits and service to our employees Support APAC benefits projects and implementation related projects from beginning to end including benefits communication creation Develop and maintain policies and other documentation to educate all employees about the companys benefits programs. You'll be asked to work from office 2 days a week. What Were Looking For: Basic Required Qualifications: 4 years' minimum benefits experience Fluent English Exposure to managing benefits plans including benefits related regulatory and tax requirements Benefits project management skills. Capable of managing multiple tasks in an organized manner whilst interacting with various external and internal stakeholders Ability to engage and communicate effectively with employees and stakeholders while understanding their needs Microsoft Excel and PowerPoint experience. A self-starter that is motivated to achieve results whilst also being a team player Accurate, with great attention to detail A positive, flexible and proactive approach Additional Preferred Qualifications: German or French language will be beneficial Bachelor's degree desirable Workday knowledge is a plus If you meet the above qualifications and are passionate about designing and managing employee benefit programs, we would love to hear from you. Return to Work Have you taken time out for caring responsibilities and are now looking to return to workAs part of our Return to Work initiative, Restart, we are encouraging enthusiastic and talented returners to apply, and will actively support your return to the workplace. Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. Recruitment Fraud Alert If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, pre-employment training or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here. ---- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ---- HUMRES202.1 - Middle Professional Tier I (EEO Job Group)
Posted 6 days ago
0.0 years
0 Lacs
mumbai, maharashtra, india
Remote
Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications. Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices. Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits. Developed and maintained regulatory strategies to support new product development and lifecycle management. Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations. Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance. Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards. Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development. Assisted in responding to regulatory queries, deficiency letters, and inspection findings. Managed regulatory documentation archives and maintained compliance records for audits and inspections. Show more Show less
Posted 1 week ago
3.0 - 5.0 years
4 - 8 Lacs
bengaluru
Work from Office
About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shared Services, helping the worlds leading recruitment companies bring their vision to life enabling them to improve outcomes by converging around the candidate, connecting expertise with unique insights into the candidate experience.Build a proactive sourcing plan and identify sourcing channels and tactical strategies that are aligned to the goals of organization and ensures best talent is identified and attracted by the company. What are we looking for? Written and verbal communicationDetail orientationCritical ThinkingProblem Management" Excellent communication skills, Uses professional, error-free grammar and formatting in emails Speaks with clarity, warmth, and confidence during virtual interactions."US/Canada recruitment Experience is a Must haveATS/ Job boards/ HCM Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shiftsAssociate will be responsible for performing day to day task per the recruitment process guidelines:1. Create approved requisition.2. Conduct internal sourcing - post requisition3. Conduct external sourcing - mine existing talent pool4. Conduct external sourcing - Post job5. Perform data mining for additional candidates6. Support candidate intake (application/expression of interest) using electronic, phone or paper methods.7. Develop list of candidates to be screened8. Automated Candidate Screening & Assessment (Interactive Voice Response (IVR) 9. Conduct hiring manager interaction Qualification Any Graduation
Posted 1 week ago
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