AGM / DGM Regulatory Affairs

Humano Forte; Pune District; Presencial; INR 3 500 000 - 7 000 000; Tempo integral

Resumo da oferta

Humano Forte is seeking a seasoned Regulatory Affairs leader to head global regulatory operations from its Pune base. The role involves developing strategies for registrations, lifecycle management, and market expansion across multiple regions, while guiding cross-functional teams to ensure compliant and timely submissions.

The successful candidate will drive regulatory intelligence, oversee CTD/eCTD dossiers, and maintain strong external partnerships with authorities, consultants, and

Qualificações

• 11+ years of regulatory affairs experience.
• Bachelor or Master in Pharmacy required (B. Pharma / M. Pharma).

Responsabilidades

• 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.

Formação académica

11+ years experience in Regulatory Affairs

B. Pharma / M. Pharma

Descrição da oferta de emprego

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.