General Manager - Regulatory Affairs

MAJOR RESPONSIBILITIES :

Key Responsibilities

1. Regulatory Strategy & Compliance Russia & CIS

• Develop and execute regulatory strategies for new 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 15) 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:

• Masters 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