Strides Pharma Science is recruiting for the position of Executive/Senior Executive – Regulatory Affairs (Europe and UK Market) in Bengaluru, Karnataka. The role focuses on regulatory CMC submissions, CTD dossier compilation, eCTD publishing, regulatory query responses, and lifecycle management activities for European and UK markets.
Candidates with 1–6 years of experience and an M.Pharm qualification can explore this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | Strides Pharma Science |
| Job Title | Executive/Senior Executive – Regulatory Affairs |
| Specialization | Europe and UK Market |
| Job Location | Bengaluru, Karnataka |
| Experience | 1–6 years |
| Qualification | M.Pharm in any specialization |
| Employment Type | Full-time, Permanent |
| Number of Openings | 2 |
| Industry | Pharmaceutical & Life Sciences |
Positions
- Executive – Regulatory Affairs (Europe and UK Market)
- Senior Executive – Regulatory Affairs (Europe and UK Market)
Job Responsibilities
- Compile regulatory submission documents for CMC and labelling requirements in European and UK markets.
- Prepare new application and lifecycle management CTD dossier modules from M1 to M5.
- Prepare responses to quality and administrative deficiencies within defined timelines.
- Respond accurately and promptly to Health Authority questions related to CMC submissions.
- Develop and implement regulatory CMC strategies for new Marketing Authorisation Applications (MAAs), post-approval changes (PACs), variations, and lifecycle activities.
- Coordinate with cross-functional teams for document requests, reviews, and regulatory submissions.
- Upload and publish documents using eCTD software.
- Arrange and coordinate departmental training sessions.
- Critically review submission documents for internal consistency.
Eligibility and Qualifications
- Educational Qualification: M.Pharm in any specialization.
- Work Experience: 1–6 years.
- Experience in regulatory affairs, particularly CMC dossier compilation and eCTD software for European and UK markets.
Required Skills
Candidates should have knowledge or experience in the following areas:
- Regulatory Affairs
- Europe and UK regulatory markets
- CTD and eCTD dossier compilation
- CMC submissions
- Regulatory submissions and documentation
- Health Authority query responses
- New Drug Applications (NDA)
- ICH guidelines
- DMF documentation
- Regulatory lifecycle management
