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 firstname.lastname@example.org
Department: API – Regulatory Affairs
Job Title : Executive / Senior Executive
Work Location : Nacharam, Hyderabad
Experience: 3 to 5 years
Qualification : MSc – Organic/Analytical Chemistry
- Compilation, review and submission of DMF as per the current regulatory requirements to regions US, Europe, EDQM and RoW.
- Preparing and submitting responses to queries from customers.
- Plant regulatory support by ensuring life cycle management and pharmacopoeia evaluation.
- Compilation and submission of Amendments to USFDA, filing of revisions to Europe.
- Maintaining and tracking the regulatory activities on-line.
- Handling Change Control Forms.
- Coordinating with other departments in obtaining documents for compilation.
- Defining control strategies for impurities based on updated guidance.