MAJOR RESPONSIBILITIES

Key Responsibilities

1. Regulatory Strategy & Compliance – Russia & CIS

- Develop and execute regulatory strategies for recent product registrations, variations, renewals, and post-approval changes for Russia & CIS markets.
- Ensure compliance with Eurasian Economic Union (EAEU) regulations, local MoH requirements, and evolving regional guidance.
- Manage end-to-end dossier preparation, review, and submission (Module 1–5) for RA dossiers in these markets.
- Track regulatory intelligence, interpret emerging regulations, and assess impact on existing and new filings.
- Build strong working relationships with regional consultants, distributors, and regulatory agencies.

2. Project Management & Cross-Functional Leadership

- Lead regulatory project management for development and commercial portfolios, ensuring milestones, timelines, and deliverables are met.
- Drive cross-functional alignment with R&D;, Quality, Manufacturing, Supply Chain, and Commercial to ensure regulatory readiness.
- Manage regulatory risk assessments and mitigation plans for product launches and variations.
- Oversee project dashboards, timelines, and governance reports for leadership reviews.

3. CDMO Technical Coordination

- Act as the primary regulatory and technical interface with Contract Development & Manufacturing Organizations (CDMOs).
- Coordinate technical data, quality documentation, and regulatory inputs required for dossier compilation.
- Monitor CDMO performance on regulatory deliverables, change controls, and technical transfers.
- Ensure alignment between CDMO activities, regulatory expectations, and internal quality systems.

4. Dossier Management & Quality Review

- Oversee high-quality CMC documentation,



formulation data, process validation, stability studies, and analytical methods for submissions.
- Review and approve regulatory sections of technical documents, artwork, labeling, and packaging components.
- Ensure robust document control, archival, and version management in line with regulatory and and audit requirements.

5. Stakeholder & Agency Interaction

- Manage agency queries, deficiency responses, and expert reviews.
- Represent the company during audits, inspections, and regulatory meetings.
- Partner with strategic teams to accelerate approvals and resolve regulatory bottlenecks.

*In addition to the above you may be given additional responsibilities as per business requirement and your JD can be altered at the discretion of your superiors.

5. Stakeholder & Agency Interaction

REQUIREMENT PROFILE:

- Master’s in Pharmacy, Life Sciences, Chemistry, or related discipline.
- 12–18+ years of strong regulatory affairs experience in pharmaceutical formulations or biologics.
- Proven experience with Russia/CIS/EAEU regulatory frameworks is mandatory.
- Demonstrated capability in regulatory project management and cross-functional leadership.
- Experience handling CDMO coordination and CMC documentation workflows.
- Strong understanding of ICH guidelines, global regulatory frameworks, and dossier structure (CTD/eCTD).
- Excellent communication, stakeholder management, and problem-solving skills.

Key Competencies

- Regulatory strategy and compliance
- Technical & CMC understanding
- Project management excellence
- Cross-functional collaboration
- Analytical thinking and decision-making
- Vendor/Partner management
- High attention to detail and documentation accuracy

📌 General Manager - Regulatory Affairs (Mumbai)
🏢 JB Pharma
📍 Mumbai