AGM / DGM Regulatory Affairs

We are hiring for leading pharma formulation company based in pune location

: Baner, Pune

: 11+ Years

: B. Phrma / M. Phrma

Roles and Responsibities -

• Lead and oversee the Regulatory Affairs department and provide strategic direction for global regulatory operations.
• Develop and implement regulatory strategies for product registrations, lifecycle management, and market expansion across LATAM, MENA, APAC, Africa, CIS, markets.
• Review and approve regulatory submission plans, registration strategies, dossiers, deficiency responses, and critical regulatory communications
• Ensure timely submission, approval, renewal, variation, amendment, and maintenance of product registrations across international markets.
• Provide regulatory assessment and feasibility evaluation for new products, portfolio expansion opportunities, licensing activities, and business development initiatives.
• Monitor global regulatory changes and assess their impact on existing products, future registrations, and business strategies.
• Establish and maintain effective relationships with international regulatory authorities, consultants, partners, manufacturers, and key stakeholders.
• Lead responses to critical regulatory deficiencies, compliance issues, inspections, audits, and health authority communications.
• Oversee preparation, review, and maintenance of CTD, ACTD, eCTD, and country-specific dossiers.
• Guide cross-functional teams including Business Development, Sourcing, Marketing, Commercial, Quality Assurance, Supply Chain, and Finance on regulatory requirements and market access strategies.
• Support licensing, in-licensing, out-licensing, contract manufacturing, and strategic partnership projects through regulatory due diligence and assessment.
• Drive regulatory intelligence activities, competitive landscape evaluation, and emerging market opportunity assessments.
• Review and monitor patent landscapes, regulatory exclusivity periods, and intellectual property considerations relevant to product registrations.
• Ensure implementation and continuous improvement of regulatory SOPs, systems, processes, trackers, and documentation controls.
• Lead departmental planning, resource allocation, workload management, and performance monitoring.
• Mentor, coach, and develop regulatory team members to build organizational capability and succession planning.
• Participate in strategic management discussions and contribute regulatory insights for business growth and long-term planning.

: [email removed]