Pharm'Up 
Healthnova, a strategic partner for pharmaceutical companies entering the UK and European markets, is hiring for its Regulatory Affairs team in Mumbai. This role is critical for managing the full lifecycle of medicinal products, from initial development to post-approval maintenance in highly regulated global markets.
Position Overview
| Category | Details |
| Job Title | Regulatory Affairs Executive / Manager – Europe |
| Location | Mumbai, India |
| Education | B.Pharm / M.Pharm (Preferred), Life Sciences, or Chemistry |
| Experience | Executive: 2–5 Years |
| Core Focus | EU Market (DCP, MRP, CP, and National procedures) |
Key Responsibilities & Expertise
The role focuses on navigating the complex regulatory landscape of the European Union. Candidates must be proficient in managing dossiers and coordinating with Contract Manufacturing Organizations (CMOs).
1. Submissions & Strategy
- Planning and executing strategies for New Marketing Authorizations (MA), line extensions, and renewals.
- Compilation and submission of dossiers using eCTD and NeeS formats.
- Hands-on management of Decentralized (DCP), Mutual Recognition (MRP), and Centralized (CP) procedures.
2. Lifecycle Management
- Managing Variations (Type IA, IB, and II) in compliance with EU Variations Regulations.
- Updating Product Information (SmPC, PIL, and Labeling).
- Addressing deficiency letters and managing “clock-stop” responses from the EMA and national authorities.
3. CMC & CMO Coordination
- Reviewing Module 3 (Quality/CMC) updates provided by European CMOs.
- Assessing regulatory impact for site transfers and manufacturing changes.
- Working with Qualified Persons (QP) to ensure supply chain compliance.
Required Knowledge Base
Successful candidates must demonstrate a practical understanding of:
- EU Pharmaceutical Legislation: Comprehensive knowledge of current directives.
- Regulatory Intelligence: Monitoring changes in EU GMP/GDP guidelines.
- Cross-functional Input: Providing due diligence for in-licensing/out-licensing deals and product feasibility.
Application Details
Interested candidates who meet the experience criteria for either the Executive or Manager level are invited to apply.
- How to Apply: Email your updated resume to nita@healthnovapharma.in or reach out via Direct Message (DM).
- Last Date to Apply: 5th February 2026
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