APL is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over US$650Mn, with presence in more than 22 countries across the globe. APL produces a wide range of Active Pharmaceutical Ingredients (API’s) and Finished Formulations which is marketed in more than 108 countries across the globe
Job Title : Executive – Regulatory Affairs
2. Review and submission of Annual Reports (ANDAs/NDAs).
3. Good interpersonal of FDA queries. Meeting agreed upon timelines. Excellent in drafting skills. Ensure adherence to high safety, quality and regulatory standards in response.
4. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplements (PAS).
5. Formulate US regulatory change controls. Knowledge of eCTD, Module-II & III.
6. Preparing quarterly and monthly targets. Allotting and evaluating targets of the team.
7. SOP identification, preparation, review and implementation
1. Should have good communication skills & be fluent in English.
2. Should have good interpretation skill for ICH and FDA guidelines.
3. Should have work experience in US market in CMC.
4. Work experience in Labeling & Module-I will also be eligible.
- UG -B.Pharma
- PG – M.Pharma