Dra - Regulatory Dept (europe & Canada) - Sr. Executive, Manager Pune
- Veko Care
- 8 - 13 years
- Pune
- 8 days ago
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Job Description
Key Responsibilities
1. Dossier Preparation & Submission
Prepare, compile, review, and submit EU CTD/eCTD dossiers (Modules 15) for pharmaceutical finished formulations.
Ensure accuracy, completeness, and compliance of dossiers as per EU guidelines (EMA/ICH).
Coordinate with internal teams (R&D, QA, QC, F&D, Packaging) for timely collection of data required for dossier compilation.
2. Regulatory Strategy & Planning
Develop regulatory strategies for new product development for EU markets.
Assess regulatory requirements for new molecules, new dosage forms, and technology transfers.
Provide regulatory inputs during product development and scale-up stages.
3. Variations & Post-Approval Activities
Handle post-approval changes/variations (Type IA, IB & Type II variations) as per EU regulations.
Maintain product lifecycle documentation and ensure continuous compliance of approved dossiers.
Track, prepare, and submit renewals as per regulatory timelines.
4. Regulatory Compliance
Ensure adherence to EU GMP, EMA, and ICH guidelines for all regulatory submissions.
Review and approve artwork, labeling, and packing components for EU compliance.
Monitor updates in EU regulatory requirements and implement relevant changes proactively.
5. Communication & Coordination
Liaise with European Regulatory Agencies, Clients, and Partners for submission queries and technical clarifications.
Respond to regulatory queries (deficiency letters) within stipulated timelines in coordination with internal stakeholders.
Participate in regulatory audits and provide necessary documentation support.
6. Documentation & Database Management
Maintain and update regulatory databases for EU submissions, approvals, renewals, and commitments.
Ensure proper archival of all regulatory documents and controlled copies.
Review technical documents, stability data, process validation, analytical method validation reports, etc.
7. Cross-Functional Support
Support QA, QC, Production, and Supply Chain teams for regulatory compliance during product launches and ongoing operations.
Support artwork development and approval processes for EU packaging requirements.
Assist in change control management and evaluation of regulatory impact.
B.Pharm / M.Pharm / M.Sc in related fields.
8 to 13 years of hands-on experience in Regulatory Affairs (DRA) for Europe/Advanced Markets.
Experience working with EU filings for tablets, capsules, injectables, or other finished dosage forms.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Legal & Regulatory - OtherRole: Legal & Regulatory - OtherEmployement Type: Full timeContact Details:
Company: Veko CareLocation(s): Pune
Keyskills: Regulatory Submissions Drug Regulatory Affairs EU GMP Canada Dossier Preparation Regulatory Affairs Eu Market Highly Regulated market Europe Market Pharmaceutical
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