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 chance 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 protected]

📌 AGM / DGM Regulatory Affairs (Pune)
🏢 Humano Forte
📍 Pune