Job Title: Regulatory Affairs Professional (US & EU Markets)
Company: Aurobindo Pharma Limited
Location: APLRC1, Hyderabad
About Aurobindo Pharma Limited:
Aurobindo Pharma Limited is a global pharmaceutical leader, committed to providing high-quality, affordable medicines worldwide. We pride ourselves on innovation and excellence in generic pharmaceutical manufacturing, driven by a dedicated team. Our significant presence in key international markets allows us to make a lasting impact on global health.
About the Opportunity:
We are actively seeking experienced and talented Regulatory Affairs professionals to join our dynamic team in Hyderabad, specifically focusing on the critical US and EU markets. This challenging fixed-term contract role offers a unique chance to contribute to our mission by ensuring the compliant registration and maintenance of our diverse product portfolio across these key international territories. If you are passionate about regulatory excellence and thrive in a fast-paced environment, we encourage you to explore this opportunity.
Key Responsibilities:
- Manage and execute US regulatory registrations (ANDA, NDA, 505(b)(2)) and EU registrations (Centralized, Decentralized, MRP, National).
- Prepare and manage all post-approval submissions for both US and EU markets.
- Ensure accurate dossier preparation and comprehensive review, adhering strictly to USFDA and EMA guidelines.
- Oversee eCTD publishing activities, guaranteeing compliance with all relevant regulatory standards.
- Interpret and apply USFDA and EMA regulations effectively, providing expert guidance on regulatory requirements.
- Develop, review, and maintain product labeling in strict accordance with US Labeling and EU Labeling guidelines.
- Collaborate cross-functionally with R&D, manufacturing, and commercial teams to support product development and market access strategies.
Qualifications & Experience:
- Education: M. Pharmacy, B. Pharmacy, or M.Sc.
- Experience: A minimum of 2 to 12 years of hands-on experience in Regulatory Affairs.
- Product Expertise: Proven experience with Oral Solid Dosages (OSD), Injectables, Biologics/Biosimilars, and Oncology products.
- Regulatory Knowledge (US & EU):
- Strong understanding of US registrations, post-approval processes, eCTD publishing, dossier preparation, USFDA regulations, and labeling.
- Strong understanding of EU registrations (Centralized, Decentralized, MRP, National), post-approval processes, eCTD publishing, dossier preparation, EMA regulations, and labeling.
- Skills: Excellent analytical, communication, and organizational skills, with meticulous attention to detail.
Important Notes:
- This position is offered on a fixed-term contract basis.
- Candidates who have interviewed with Aurobindo Pharma Limited for any role within the last six months are not eligible to apply for this particular opening.
How to Apply:
If you are a highly motivated Regulatory Affairs professional ready to take on a challenging and rewarding role, we encourage you to apply. Interested candidates should submit their updated CVs, clearly highlighting their latest experience and relevant qualifications.
For efficient review of your application, please ensure you use the specific subject line for your submission:
- For US Market roles: “Application for RA- US market”
- For EU Market roles: “Application for RA- EU market”
Please refer to our official company careers portal or dedicated recruitment advertisements for precise submission instructions and contact details. We look forward to connecting with qualified individuals who are passionate about regulatory excellence.
