Regulatory Affairs-Deputy Manager/Manager
12 - 15 Years of Experience
Not disclosed 
Full TimeCentaur Pharmaceuticals Pvt. Ltd
Ambernath, Maharashtra, India
Posted on 19-12-2022
1 Vacancy
Description
- Timely submission of USDMF ASMP/CEP in all regions (US/EU CA Brazil and ROW).
- Good exposure in eCTD submission with respect to global submission requirements (US, Canada, ELEMA (ASME), CEP TGA, Brazil, China, Taiwan & ROW.
- Post approval amendments to authorities and customers.
- Review of all DMPs & Amendments for EU, US, Canada, and Japan. China, Taiwan, Brazil & another region.
- Propagation of response to all regulatory queries.
- Responding to all customer queries.
- DMF life cycle management.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MSc (Master of Science)MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)
Key Skills
Critical ThinkingPharma IndustryRegulatory AffairsDeputy Manager/Manager
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