Watson Pharmaceuticals, Inc., headquartered in Corona, California, is a leading global speciality pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology, Women's Health and Nephrology (Medical). Watson has commercial operations in many of the world's most established and growing international markets.
Post: Officer / Executive / Asst. Manager - Regulatory Affairs
Job Description:
1. Quality Compilation of ANDA, Supplements and Quality Review of all Submission Documents as per current regulatory requirements.
2. Preparation, review, and maintenance of allotted regulatory submissions i.e. original applications, amendments, supplements, and responses to deficiency letters.
3. Review of documentation during generation before the execution
4. Interpretation of standard guidances by USFDA, ICH against product execution confirming suitability in regulatory submissions.
5. To compile ANDA and Site Transfer Supplements
Candidate Profile:
• 1 to 3 years of experience in similar industry.
• Should have worked in regulatory affairs function in Pharma industry for regulated markets.
• Should have experience in preparation and review of ANDAs, and Site Transfer Supplements in CTD format
Additional Information:
Experience: 1-3 years
Location: Vasco
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Apply/Send resume at, Recruitment.Goa@Watsonpharm.co.in
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