API Regulatory Affairs - DMF Filing Biocon Ltd

11.0 - 18.0 years

0 Lacs

karnataka

On-site

Role Overview: As an Associate Manager / Manager in API Regulatory Affairs - DMF Filing/ Compilation for the global market, your responsibilities will include: - Hands-on experience in Regulatory Affairs-API/DMF Filing/DMF Compilation/ Submission/ Customer Communication. - Compiling and submitting DMFs globally for small molecule APIs in eCTD format, ensuring compliance with ICH and region-specific regulatory guidelines (EU, US, Canada, Japan, Australia, Brazil, China, South Korea, etc.). - Demonstrating good knowledge of all regulatory guidelines and API Regulatory processes. - Compiling responses to queries from Regulatory Agencies & customers globally, meeting specified timelines for subm...

Posted 3 weeks ago

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Project Manager - Pharma - CDMO Hyderabad SAI Life Sciences

10.0 - 16.0 years

9 - 15 Lacs

hyderabad

Work from Office

Department: Project Management Location: Shameerpet About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity ...

Posted 1 month ago

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AM/DM - Project Management - Pharma - CDMO Hyderabad, 7 To 12 Years SAI Life Sciences

7.0 - 12.0 years

6 - 11 Lacs

hyderabad

Work from Office

Department: Project Management - Assistant Manager / Deputy Manager Location: Shameerpet About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace di...

Posted 2 months ago

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