Senior Regulatory Affairs Specialist
7 days ago
Role -Team Lead - International Regulatory Affairs Location - Bangalore Industry - Pharmaceutical Required Experience :- 10-15 years Education :- M.Pharma / M.ScMust have experience in IRA handling regulated or unregulated region and submissions, handling a team of 2 for submission Will lead a team of atleast 10 people(Team Leading exp is mandatory) Good understanding experience in handling regulated markets. Evaluation andRegulatory Impact Assessment of Change Controls and Deviations. Understanding and awareness of regulated markets region Pharma regulations with country specific requirements, checklists guideline on latest regulations Ability to contribute to Plan and execute Dossier Compilation Ensure timely Review and Submission to Health Authorities of assigned regulated markets Planning and Submission of Amendments / Supplements Timely submission of Responses to the Queries received from various Regulatory Authorities. Oversees country compilation, quality review and submissionof country specific applications Develop and maintain relationships regulated markets team in alignment with allotted projectsApplicants with relevant experience can email their resumes to poornima.c@classicsearchplc.com
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Regulatory Affairs Specialist
1 week 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 Specialist
5 days ago
New Delhi, India UpMan Placements Full timeCore Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA Prepare and submit...
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Senior Manager Regulatory Affairs
7 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
2 weeks 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
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 (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and...
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Regulatory Affairs Manager
4 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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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 (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
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Regulatory Affairs Manager
3 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
3 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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Senior Manager Regulatory Affairs
2 weeks 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 regulatory...