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RA chem Pharma ltd hiring for a Executive/Senior Executive in API – Regulatory Affairs

Job Description:

Department API- Regulatory Affairs

Job Title: Executive / Senior Executive Work Location: Nacharam, Hyderabad

Experience: 3 to 5 years

Qualification : MSc – Organic/Analytical Chemistry

1. Compilation, review and submission of DMF as per the current regulatory requirements to regions US, Europe, EDQM and ROW.

2. Preparing and submitting responses to queries from customers.

3. Plant regulatory support by ensuring life cycle management and pharmacopoeia evaluation.

4. Compilation and submission of Amendments to USFDA, filing of revisions to Europe.

5. Maintaining and tracking the regulatory activities on-line.

6. Handling Change Control Forms.

7. Coordinating with other departments in obtaining documents for compilation.

8. Defining control strategies for impurities based on updated guidance.

Interested candidates can please share your resume to madhavi.p@rachempharma.com

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