Centaur Pharmaceuticals Recruiting For Sr. Executive / Asst. Manager – Regulatory Affairs .In 1978, Centaur Pharmaceuticals, commenced pharmaceutical manufacturing operations in Mumbai and has now evolved into a vertically integrated pharmaceutical company. Centaur House, our corporate headquarters, is located in Mumbai, the commercial capital of India. Centaur has a strong matrix of capabilities across the pharmaceutical value chain including API, formulations, Contract Research and Manufacturing Services, Clinical Research, R&D, regulatory and marketing.
Eligibility and other details :
- Post Name: Sr. Executive / Asst. Manager – Regulatory Affairs
- Qualification:B.Pharma,M.Pharma,B.Sc,M.Sc with 04-08 Years of Experience
- Location: Mumbai
- Salary:Not Disclosed
- No Vacancies: 01
- Selection Process : Based on Resume Received,will shortlist.
Job description:
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Prepare CMC documentation (dossiers) for regulatory submission, with support and guidance, assuring regulatory compliance, meeting agreed upon timelines and eCTD publishing requirements – Prepare CMC responses to deficiencies received from regulatory agencies – Maintenance of approved ANDAs and Marketing Authorizations (MAs) – Review and evaluation of change controls and various other quality documents (e.g. Deviations, IR etc) for regulatory impact – Keep knowledge up to date with regard to regulatory guidelines
