Strides is hiring for Executive and Senior Executive – Regulatory Affairs for its Regulatory Affairs department, focusing on the Europe and UK markets. Candidates with an M.Pharm qualification and 2–6 years of experience can apply for this opportunity in Bengaluru.
Job Details
| Particulars | Details |
|---|---|
| Company | Strides |
| Job Title | Executive / Sr. Executive – Regulatory Affairs |
| Department | Regulatory Affairs |
| Market | Europe and UK |
| Experience | 2–6 years |
| Qualification | M.Pharm |
| Job Location | Bengaluru |
| Application Email | sivashankar.mohanty@pivotpath.com |
Positions Available
- Executive – Regulatory Affairs
- Senior Executive – Regulatory Affairs
Key Responsibilities
Selected candidates will be responsible for the following activities:
- Compile documents for regulatory projects and submissions related to Chemistry, Manufacturing and Controls (CMC) and labelling requirements for Europe and the UK.
- Prepare new application and lifecycle management CTD dossier modules from M1 to M5.
- Interpret and prepare responses to quality and administrative deficiencies within defined timelines.
- 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 submission requirements.
- Upload and publish documents using electronic Common Technical Document (eCTD) software.
- Arrange and coordinate departmental training sessions.
- Critically review submission documentation to ensure internal consistency.
Eligibility and Qualifications
Candidates must meet the following criteria:
- Educational Qualification: M.Pharm
- Experience: 2–6 years
- Location: Bengaluru
Required Skills and Knowledge
The role involves regulatory documentation and submission activities. Relevant areas of work include:
- Regulatory Affairs for Europe and UK markets
- CMC documentation and labelling
- CTD dossier compilation, including Modules M1–M5
- Regulatory deficiency response preparation
- Regulatory CMC strategies and lifecycle management
- eCTD publishing and submission documentation review
- Cross-functional coordination
How to Apply
Interested candidates can share their profiles by email.
Email: sivashankar.mohanty@pivotpath.com
