Crescent Pharma Hiring Regulatory Affairs – EU Market
- Exciting Regulatory Affairs Job Opportunity for Experienced Pharma Professionals in Thane
- Company Overview
- Job Location
- Required Education
- Key Responsibilities
- New Submissions:
- Post-Approval Life Cycle Management:
- Eligibility Criteria
- Career Benefits
- How to Apply
- Related Education Courses
- Quick Overview Table
Regulatory Affairs Jobs in Thane – B Pharm, M.Pharm, MSc Graduates (6–15 Yrs Experience) | Crescent Pharma
Apply for Regulatory Affairs openings in Thane at Crescent Pharma. Suitable for B Pharm, M.Pharm, MSc professionals with 6–15 years experience in EU submissions.
Exciting Regulatory Affairs Job Opportunity for Experienced Pharma Professionals in Thane
Crescent Pharma is inviting experienced candidates with a strong background in Regulatory Affairs to apply for positions focused on new submissions and post-approval life cycle management for the Europe (EU/UK) market. These are full-time, work-from-office positions based in Thane, Maharashtra, and are ideal for professionals who have hands-on experience in dossier preparation, variation submissions, and regulatory compliance.
Company Overview
Crescent Pharma is a fast-growing pharmaceutical company known for its robust regulatory framework, a global footprint, and consistent commitment to quality compliance. This is your opportunity to become a part of a regulatory team that works across major global markets.
Job Location
- Thane, Maharashtra
- Work Mode: Work From Office
- Work Days: 5 Days a Week
Required Education
- B Pharm (Bachelor of Pharmacy)
- M.Pharm (Master of Pharmacy)
- MSc (Master of Science – Chemistry, Biotechnology, Life Sciences)
Key Responsibilities
New Submissions:
- Preparation, registration & submission of regulatory dossiers to the EU or UK and other regulated markets.
- Compilation and review of regulatory variations (Type IA/IB/II).
- eCTD publication of new applications, variations, renewals, and PIQ.
- Submission of applications including Change of Ownership, Piggyback applications.
- Use of portals such as CESP and other country-specific regulatory gateways.
Post-Approval Life Cycle Management:
- Manage the end-to-end post-approval life cycle for EU/UK markets.
- Handle variations and renewal submissions.
- Expert knowledge of Module 1 and Module 3 documentation.
- Liaise with internal stakeholders and regulatory agencies to ensure accurate and timely submissions.
- Ensure compliance by maintaining updated dossiers.
Eligibility Criteria
- Minimum 6 to 15 years of hands-on experience in Regulatory Affairs.
- Must have experience handling EU and UK submissions.
- Familiarity with regulatory documentation, guidelines, and variations.
- Strong communication and coordination skills.
- Only candidates willing to work full-time from Thane office need apply.
Career Benefits
- Be part of a reputable and growing pharmaceutical organization.
- Gain exposure to global regulatory markets (EU/UK).
- Work in a structured, compliance-driven environment.
- 5-day work week with excellent work-life balance.
How to Apply
If you meet the above qualifications and are interested in this exciting career opportunity, send your updated resume to:
gsingh@crescentpharma.com
Related Education Courses
B Pharm, M.Pharm & MSc may include the following streams:
- B Pharm – General Pharmacy, Clinical Pharmacy, Pharmaceutical Chemistry
- M.Pharm – Pharmaceutics, Regulatory Affairs, Pharmacology
- MSc – Organic Chemistry, Biotechnology, Life Sciences, Pharmaceutical Sciences
Quick Overview Table
| Company Name | Crescent Pharma |
|---|---|
| Department | Regulatory Affairs – EU Market |
| Required Education | B Pharm / M.Pharm / MSc |
| Experience | 6 to 15 Years |
| Job Location | Thane (Work From Office) |
To apply for this job email your details to gsingh@crescentpharma.com
