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Pharma Candidates Work as Executive @ Aurobindo Pharma Ltd

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

No.of.Posts : 2
Experience : 2 – 4 Years
Location : Hyderabad
Salary : INR 2,25,000 – 6,00,000 P.A.
Job Description:
1. Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adhere to high quality and regulatory in dossiers.
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
Required Skills:
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.
Education:
  • UG -B.Pharma
  • PG – M.Pharma

Click here to Apply Online

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