RA Chem Pharma Ltd Job Vacancy Msc Organic/Analytical Chemistry

RA Chem Pharma Ltd Job Vacancy Msc Organic/ Analytical Chemistry

 

RA Chem Pharma Ltd Job Vacancy Msc Organic/Analytical Chemistry

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

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

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