DRA - Regulatory Dept (Europe & Canada) - Sr. Executive, Manager Pune

Key Responsibilities

1. Dossier Preparation & Submission

EU CTD/eCTD dossiers

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

EU GMP, EMA, and ICH guidelines

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

European Regulatory Agencies, Clients, and Partners

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.