Regulatory Affairs US or EU Market

Aurobindo Pharma is looking for experienced Regulatory Affairs professionals with strong expertise in US FDA or EU regulatory requirements. The ideal candidates should have hands-on experience in regulatory submissions, compliance activities, and lifecycle management within the pharmaceutical industry.

Location: APLRC-1, Hyderabad

Open Positions.

Key Responsibilities

Preparation and submission of ANDA filings.

Handling Post Approval (Life Cycle Management - LCM) activities.

Regulatory support for Semi-Solid Dosage Products (SPD), Topical and Dermatological formulations.

Coordination with cross-functional teams to ensure timely regulatory submissions.

Compliance with US FDA regulatory requirements.

Educational Qualification

B.Pharm / M.Pharm

Specialization in: Regulatory Affairs

Pharmaceutics

Required Experience

4.5 to 6 years of experience in the US Regulatory Affairs domain.

Key Responsibilities

Preparation and management of EU Pre-Approval and Post-Approval submissions.

Handling CMC (Chemistry, Manufacturing & Controls) documentation.

Managing Life Cycle Management (LCM) activities for EU markets.

Ensuring compliance with European regulatory requirements.

Supporting product registrations and regulatory maintenance activities.

Required Experience

2 to 5 years in EU CMC – Post Approval activities.

8 to 12 years in EU CMC – Life Cycle Management (LCM).

Educational Qualification

M.Pharm

Specialization in:

Regulatory Affairs/Pharmaceutics

/Pharmaceutical Analysis/Quality Assurance

APLRC-1, Hyderabad

Interested candidates are invited to send their updated resume to:

For US Market Opportunities

Email: Sreeja.Yangam@aurobindo.com

For EU Market Opportunities

Email: Pooja.Uppalapati@aurobindo.com