Regulatory Affairs Associate
4 days ago
Hi Everyone,I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.Please refer below JD and share your profile on pallavi.ag@peoplefy.comExperienced in preparing, review and compile regulatory submissions. Maintain compliance with US FDA and ICH requirements. Should have experienced in pre-submission activity. Experienced in CMC. Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format. Maintain compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines. Author and review high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS). Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact. Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data. Support regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses. Review and approve change controls from global manufacturing partners to assess regulatory impact. Stay current with FDA guidance, ICH regulations, pharmacopeial requirements, and industry updates.Thank you
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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 , 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
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
2 weeks ago
new delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, 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
4 weeks ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of 2015-16, 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 DescriptionFounded in the commercial operations year of 2015-16, 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
1 week 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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Executive - Regulatory Affairs
2 weeks ago
Delhi, Delhi, India Domnic Lewis Pvt. Ltd Full time**Executive - Regulatory Affairs - Delhi**: **Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs - Delhi** **Position Title**: Executive - Regulatory Affairs **Grade**: C **Reports to**: Lead/Manager - Regulatory Affairs **Position Purpose**: - Monitor and report the status of all product licenses in a timely and accurate manner -...
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Regulatory Affairs Officer
2 weeks ago
Delhi, India ProductLife Group Full timeResponsibilities In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more!Compile, or supervise the compilation of regulatory dossiers Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and...
