Job Title: Regulatory Affairs (US Markets)
Company: Leading Pharma company in Hyderabad Location
No. of Positions: 5
Division: Formulation Injectables
Department: Regulatory Affairs
Job Location: Hyderabad Location
Qualification: B.Pharma / M.Pharma
Years of Experience: 2 to 4 Years
Salary Range: 6 LPA (Max)
Contact person: Mr.Zabi Moghal
Roles & Responsibilities:
- Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality and regulatory standards in dossiers.
- Review and submission of Annual Reports (ANDAs/ NDAs).
- Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality and regulatory standards in response.
- Evaluation and good interpretation of Post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).
- Knowledge of Ectd, Module 2 and 3.
- Formulate US regulatory filing strategy for new projects.
- Good interpersonal skill for ICH & FDA guideline.
- SOP identification, preparation, review & implementation.
- Working in close partnership with other department like: FRD/ FRAD/ DMF holders/ QA etc.,
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Full Time, Permanent