Welcome to Sun Pharma Baroda, where regulatory compliance meets innovation in pharmaceuticals! As a Regulatory Affairs Executive/Sr. Executive, you have the unparalleled opportunity to navigate the dynamic landscape of pharmaceutical regulations while contributing to Sun Pharma’s mission of providing high-quality healthcare solutions globally.
In this pivotal role, you’ll spearhead regulatory strategies, ensuring that our products meet stringent guidelines while optimizing market access. Leveraging your expertise in regulatory affairs, you’ll collaborate cross-functionally to expedite product approvals, uphold compliance standards, and drive strategic initiatives that propel Sun Pharma’s growth trajectory.
| Designation | Executive/Sr. Executive |
| Department | Regulatory Affairs |
| Qualification | M.Pharm |
| Experience | 3-7 years |
Job Description:
1) Review all data and documents related to product registrations for various health authorities.
2) Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
3) Prepare responses to deficiency letters received from various agencies.
Maintain life-cycle / post approval changes for drug product registration dossiers.
4) Provide regulatory support to cross functional departments.
5) Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway.
Send your resume to: Hr.Tandalja@sunpharma.com
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