Regulatory Affairs
1 week ago
Position Overview: We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includesLifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities: PrepareVariation documents and/or evaluate post-approval CMC changesin compliance with global regulatory requirements. Contribute toLifecycle Management (LCM) activitiesby helping to compile and review CTD dossier modules. Compile initial dossiers(Modules 2 & 3)forUS / EU / SA / WHO / ANZ / Other Countries . Provide regulatory strategies and conduct evaluations of post-approval CMC changes consideringICHand country-specific guidelines. Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries. UtilizeVeeva Vault RIMto track queries and manage submission workflows. Review technical documents from manufacturing sites, including: Specifications Batch Manufacturing Records Process & Analytical Validations Batch Analysis Data Stability DataExperience Requirement: 3+ years of experience in managingInitial submissions ,Variations , and fullLCM (Lifecycle management)deliverables for the global markets. Must have experience with Veeva Vault RIM Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ ANZ/Other countries. Review of technical documents from manufacturing sites like of Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc.required for compilation of dossier sections/Variations. Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other countries(Module 2 & 3). Experience in providing Regulatory strategies/ Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements. Compilation and submission of Variations/ supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.
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Regulatory affairs manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , Next Gen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
3 weeks ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
2 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
2 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Specialist
4 days ago
New Delhi, India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej Crossroads Department:RA Reports To:RA Head and Regulatory Department at HO /Director Employment Type:Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive...
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Regulatory Affairs Executive
2 weeks ago
New Delhi, India Euronoxx Reserves ltd Full time**Regulatory Affairs Manager** **Benefits** JOB TYPE: Permanent EMPLOYMENT TYPE: Full-Time EXPERTISE: PHARMACEUTICAL REGULATORY AFFAIRS SALARY TYPE: Annually SALARY: Negotiable REPORTS TO: Managing Director VACATION LEAVE: paid LOCATION: Shimla, Himachal Pradesh, India. This role will be office-based or hybrid **REQUIRED: Direct experience working...
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Senior Manager Regulatory Affairs
3 days ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and...
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Senior manager regulatory affairs
1 week ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: M. Sc. / Ph. D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals) Role: The role is responsible for global product registrations (Lat Am, Africa, GCC etc.), WHO Prequalification, Product lifecycle...
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Senior Manager Regulatory Affairs
4 days ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals) Role: The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and...
