RA Chem Pharma Limited – Hiring for API – Regulatory Affairs

RA Chem Pharma Limited is a vertically integrated pharmaceutical company. Over the past 15 years, it has expanded its spectrum by establishing state-of-the-art manufacturing facilities in API, Formulations and Clinical Research.

Greetings for the Day!!!

We are hiring for a Executive/Senior Executive in API – Regulatory Affairs

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

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

Job Description:

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.

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