Aurobindo Pharma Regulatory Affairs Vacancies in Hyderabad

Career Opportunities in Regulatory Affairs at Aurobindo Pharma

Aurobindo Pharma, a leader in the pharmaceutical industry, is currently hiring for multiple positions in their Regulatory Affairs department in Hyderabad. This is an excellent opportunity for professionals with an M.Pharm degree and relevant experience to contribute to the timely approval of life-saving treatments.

Open Positions in Regulatory Affairs

US Market – Post Approval

Experience: 3 to 6 Years
Qualification: M.Pharm (any specialization)
Key Skills: Handling Post-approval Activities, CB-0, CB-30, PASS, FDA Inspections
Location: APL Research Centre – 1, Sy No. 313 & 314, Bachupally, Hyderabad

Aurobindo Pharma is looking for experts to manage post-approval regulatory activities for the US market. The ideal candidate will have experience in handling post-approval activities and FDA inspections, ensuring compliance with regulatory requirements.

US Market – CMC

Experience: 3 to 6 Years
Qualification: M.Pharm (any specialization)
Key Skills: Knowledge of Chemistry, Manufacturing, and Controls (CMC) documentation, regulatory submissions
Location: APL Research Centre – 1, Sy No. 313 & 314, Bachupally, Hyderabad

This role focuses on the preparation and submission of CMC documentation to ensure the continuous approval of pharmaceutical products in the US market. Candidates should have a thorough understanding of CMC requirements and regulatory submissions.

EU Market – Module 3

Experience: 3 to 6 Years
Qualification: M.Pharm (any specialization)
Key Skills: Preparation and submission of Module 3 documentation, handling EU regulatory submissions
Location: APL Research Centre – 1, Sy No. 313 & 314, Bachupally, Hyderabad

Candidates for this position will be responsible for the preparation and submission of Module 3 documentation for the EU market. The role requires a deep understanding of EU regulatory requirements and the ability to handle complex regulatory submissions.

EU Market – Module 1

Experience: 3 to 10 Years
Qualification: M.Pharm (any specialization)
Key Skills: Administration, preparation, and submission of renewals, response to agency queries, RSI & RFI
Location: APL Research Centre – 1, Sy No. 313 & 314, Bachupally, Hyderabad

This position involves handling the preparation and submission of Module 1 documentation for the EU market. The candidate should have experience in managing renewals, responding to agency queries, and handling regulatory submissions.

How to Apply

Interested candidates are encouraged to send their resumes to the following email address: Email: hrrc1@aurobindo.com