Healthnova is the ideal partner for pharmaceutical companies intending to enter the UK and European market. Healthnova can support and manage the full product lifecycle management from development to registration to sales of product both in the United Kingdom and mainland Europe through dedicated team of experts. Healthnova team has more than decade experience in pharmaceutical marketing and distribution of products in Global markets.
Job Title : Regulatory Affairs Executive / Regulatory Affairs Manager - Europe
Department : Regulatory Affairs
Reporting to : Head of Regulatory Affairs / Managing Director / Regional RA Head
Location : Mumbai
Role Purpose
To manage and support European regulatory activities for medicinal products across the EU lifecycle, including new registrations, variations, renewals, and regulatory maintenance, while coordinating with EU CMOs, MAHs, and regulatory authorities to ensure full compliance with EU legislation.
Key Responsibilities
EU Regulatory Strategy & Submissions
* Plan and execute regulatory strategies for:
• New MA applications
• Line extensions
• Renewals
• Variations (IA, IB, II)
* Prepare, compile, review, and submit dossiers via:
• eCTD / NeeS
• National, DCP, MRP, and CP procedures
* Liaise with European Medicines Agency and EU national competent authorities
Regulatory Lifecycle Management
* Maintain approved dossiers throughout the product lifecycle
* Manage :
• SmPC, PIL, labeling updates
• PSUR/PBRFR (where applicable) Commitments and post-approval changes
* Track regulatory deadlines and ensure on-timc submissions
CMO & Partner Coordination
* Coordinate with EU CMOs for:
• Module 3 updates
• Manufacturing changes
• Site transfers
* Review CMO-provided documents for regulatory impact
* Support Quality Agreements from a regulatory perspective
Variations, Renewals & Compliance
* Classify and manage variations as per :
• EU Variations Regulation
* Prepare and submit:
• MA renewals
• Sunset clause justifications
* Ensure regulatory compliance during:
• Manufacturing changes
• Artwork/labeling updates
• Supply chain changes
Authority Communication
* Act as primary contact with EU authorities for:
• Queries
• Deficiency letters
• Clock-stop responses
* Coordinate responses with QA, QP, CMOs, and internal stakeholders
Regulatory Intelligence
* Monitor and interpret changes in:
• EUGMP/GDP
• EMA and national authority guidelines
• Variations and eCTD requirements
* Proactively assess regulatory impact on existing portfolio
Cross-Functional Collaboration
* Work closely with :
• Quality Assurance
• Qualified Person (QP)
• Supply Chain
• Business Development
* Provide regulatory input for:
• In-licensing / out-licensing deals
• Due diligence activities
• Product feasibility assessments
Candidate Profile
Bachelor's or Master's degree in:
Pharmacy (preferred)
Life Sciences
Pharmaceutical Sciences
Chemistry
• RA Executive: 2-5 years EU regulatory experience
• RA Manager: 6-10+ years EU regulatory experience
• Hands-on experience with:
* EU MA submissions
* Variations and lifecycle management CMO-based manufacturing models
Key Skills & Knowledge
*Strong knowledge of :
• EU pharmaceutical legislation
• eCTD/NeeS
• DCP, MRP, National procedures
*Practical understanding of:
• Module 3 (CMC)
• Change control impact
• EU Variations Regulation
*Excellent written and spoken English
*Strong project management and stakeholder coordination skills
Suitable Interested Candidates Kindly DM or email their resume on nita@healthnovapharma.in
Last Date : 5th February 2026
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