About the Job :
We are hiring for a Executive/Senior Executive in API - Regulatory Affairs
Job Description:
Dept : API - Regulatory Affairs
Job Title : Executive / Senior Executive
Work Location : Nacharam, Hyderabad
Experience: 3 to 5 years
Qualification : MSc - Organic/Analytical Chemistry
Compilation and submission of Amendments to USFDA, filing of revisions to Europe.
Compilation, review and submission of DMF as per the current regulatory requirements to regions US, Europe, EDQM and RoW.
Defining control strategies for impurities based on updated guidance.
Preparing and submitting responses to queries from customers.
Plant regulatory support by ensuring life cycle management and pharmacopoeia evaluation.
Maintaining and tracking the regulatory activities on-line.
Coordinating with other departments in obtaining documents for compilation.
Handling Change Control Forms.
Interested candidates can please share your resume to [email protected]