API Regulatory Affairs
1 week ago
Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market) Level - Assistant Manager/Deputy Manager /Associate Manager Level:- Required Education/Exp :- Experience Req.: 7 yrs. - 15 yrs. Qualification: - M.Sc. / M.Pharma Responsibilities 1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc. 2. Compilation and submission of DMFs globally for small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines. 3. Should have good knowledge of all the regulatory guidelines and API Regulatory processes. 4. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline. 5. Review and submission of new DMFs, deficiency responses, amendments, updations to various regulatory agencies. 6. Evaluation of change controls and updating to agencies by considering change categories. 7. Should have hands-on experience in eCTD software Candidates with relevant exp., kindly share CVs to apply on : - Kindly mention below details while sharing CV :- Total Exp? Current CTC? Total number of DMF filings? Handling which major markets globally ? Notice Period? Ready to work in Bangalore (onsite) ? (5 Days working)
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API Regulatory Affairs
2 weeks ago
bangalore, India Biocon Ltd Full timeRole - API Regulatory Affairs - DMF Filing/ Compilation (Global market)Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs.Qualification: - M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2....
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API Regulatory Affairs
6 days ago
bangalore district, India Biocon Ltd Full timeRole - API Regulatory Affairs - DMF Filing/ Compilation (Global market) Level - Assistant Manager/Deputy Manager /Associate Manager Level:- Required Education/Exp :- Experience Req.: 7 yrs. - 15 yrs. Qualification: - M.Sc. / M.Pharma Responsibilities 1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc. 2....
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Regulatory Affairs Manager
2 days ago
bangalore, India Ixoreal Biomed Full timeAbout the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Manager
15 hours ago
bangalore, India beBeeRegulatoryAffairs Full timeWe are seeking an experienced professional to join our team as a Regulatory Affairs Manager.The ideal candidate will have 8-12 years of experience in regulatory affairs and a strong understanding of the MENA region.Key responsibilities include:Planning and maintaining client product portfoliosCompilation, review, and submission of registration...
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Regulatory Affairs Manager
2 days ago
bangalore, India Ixoreal Biomed Full timeAbout the Company:Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory AffairsExperience:8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
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Regulatory Affairs Analyst
6 days ago
bangalore, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...
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Regulatory Affairs Specialist
6 days ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or InjectablesLevel - Deputy Manager/ Associate ManagerRequired Education/Exp:Experience Req.: 8 - 12 yrs.Qualification: - M. Pharma / M.Sc.Key Role- Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities:- Drafting controlled correspondences, pre-development meetings...
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Regulatory Affairs Analyst
6 days ago
bangalore, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:...
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Regulatory Affairs Executive
1 week ago
bangalore, India Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
6 days ago
bangalore, India Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
