Strides Pharma Science Limited is Hiring Executive / Senior Executive – Regulatory Affairs (Europe & UK Market) in Bengaluru
Strides Pharma jobs offer qualified candidates an opportunity to step into the role of Executive / Senior Executive in Regulatory Affairs, focusing on the European and UK markets. This full-time position is based in Bengaluru and is suited to M.Pharm graduates with 1–6 years of relevant experience.
About the Company
Strides Pharma Science Limited is a global pharmaceutical company headquartered in India, specializing in the development and manufacturing of a wide range of pharmaceutical products. The company operates in various markets, including Europe and the UK, and is committed to delivering high-quality healthcare solutions through innovation and regulatory excellence.
Job Details:
- Position: Executive / Senior Executive – Regulatory Affairs (Europe and UK Market)
- Location: Bengaluru, Karnataka
- Openings: 2
- Type: Full-time, Permanent
Strides Pharma Regulatory Affairs Job Description
The selected candidates will be responsible for compiling regulatory submission documents for CMC and labelling for the European and UK markets. They will prepare new-application and lifecycle-management CTD dossiers (Modules 1–5), respond to quality and administrative deficiencies, and address Health Authority questions on CMC submissions within specified timelines. Additionally, they will develop and implement regulatory CMC strategies for new Marketing Authorization Applications (MAAs), manage post-approval changes and variations, and coordinate with cross-functional teams for document reviews. This Strides Pharma regulatory affairs job also involves uploading and publishing documents using eCTD software and critically reviewing submission documents for internal consistency.
Key Responsibilities
- Compile regulatory submission documents for CMC and labelling for European and UK markets.
- Prepare new-application and lifecycle-management CTD dossiers (Modules 1–5).
- Respond to quality and administrative deficiencies and Health Authority questions on CMC submissions.
- Develop and implement regulatory CMC strategies for new MAAs, post-approval changes, and variations.
- Coordinate with cross-functional teams for documents and reviews.
- Upload and publish documents using eCTD software.
- Critically review submission documents for internal consistency.
- Arrange departmental trainings.
Eligibility Criteria
- M.Pharm in any specialization.
- 1–6 years of experience in Regulatory Affairs, particularly CMC dossier compilation and eCTD software for European and UK markets.
- Knowledge of CTD/eCTD, ICH guidelines, DMF documentation, and regulatory lifecycle management is expected.
How to Apply
Interested candidates can apply online through the official job listing:
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE.
Conclusion
These Strides Pharma jobs are ideal for M.Pharm graduates looking to advance their careers in Regulatory Affairs within the European and UK markets. Qualified candidates are encouraged to apply before the deadline to seize this promising role.