Aurobindo
2-12Years
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Position: Regulatory Affairs – US & EU Markets
Department: Regulatory Affairs
Location: Hyderabad
Employment Type: Full-Time
Eligibility & Experience
US Regulatory Affairs
* Experience: 4.5–6 years
* Qualification: B.Pharm / M.Pharm (Regulatory Affairs / Pharmaceutics preferred)
EU Regulatory Affairs
* Experience:
* 2–5 years in EU CMC Post-Approvals
* 8–12 years in EU CMC Lifecycle Management (LCM)
* Qualification: M.Pharm (Regulatory Affairs, Pharmaceutics, Analysis, or Quality Assurance)
Regulatory Affairs.
Looking to build or advance your career in Regulatory Affairs? Explore an exciting opportunity to work on US and EU pharmaceutical markets with a leading pharmaceutical organization.
Key Responsibilities
* Prepare, review, and manage regulatory submissions for US and EU markets.
* Handle ANDA filings, lifecycle management (LCM), and post-approval regulatory activities.
* Support CMC documentation, dossier preparation, and regulatory compliance.
* Coordinate with cross-functional teams including R&D, QA, Manufacturing, and Supply Chain.
* Ensure submissions comply with applicable global regulatory guidelines and timelines.
Required Skills
* Hands-on experience in US and/or EU Regulatory Affairs.
* Knowledge of ANDA, CMC, Post-Approval Changes, and Lifecycle Management.
* Strong understanding of ICH guidelines and global regulatory requirements.
* Excellent documentation, communication, and stakeholder management skills.
* Ability to manage multiple regulatory projects while meeting deadlines.
Disclaimer: FYND Talent Solutions is an independent recruitment platform. This job is shared for informational purposes only and is not an official communication from the hiring company unless explicitly stated.
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