Crescent Pharma Hiring Regulatory Affairs – EU Market

Crescent Pharma Hiring Regulatory Affairs – EU Market

Regulatory Affairs Jobs in Thane – B.Pharm, M.Pharm, M.Sc Graduates (6–15 Yrs Experience) | Crescent Pharma

Apply for Regulatory Affairs openings in Thane at Crescent Pharma. Suitable for B.Pharm, M.Pharm, M.Sc professionals with 6–15 years experience in EU submissions.


Exciting Regulatory Affairs Job Opportunity for Experienced Pharma Professionals in Thane

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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)
  • M.Sc (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


B.Pharm, M.Pharm & M.Sc may include the following streams:

  • B.Pharm – General Pharmacy, Clinical Pharmacy, Pharmaceutical Chemistry
  • M.Pharm – Pharmaceutics, Regulatory Affairs, Pharmacology
  • M.Sc – Organic Chemistry, Biotechnology, Life Sciences, Pharmaceutical Sciences

Quick Overview Table

Company NameCrescent Pharma
DepartmentRegulatory Affairs – EU Market
Required EducationB.Pharm / M.Pharm / M.Sc
Experience6 to 15 Years
Job LocationThane (Work From Office)
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