Job Description: Head Regulatory Emerging market & Europe The Regulatory Head for Emerging Markets & Europe is responsible for leading regulatory activities in support of drug development, registration, and lifecycle management across the emerging markets and European regions. The role also plays a crucial part in regulatory assessments for in-licensing and out-licensing opportunities, ensuring that potential products meet regulatory requirements for smooth market entry or expansion. Key Responsibilities: 1. Regulatory Strategy: - Develop and implement regulatory strategies for new product development, market approvals, and post-approval maintenance across Europe and Emerging Markets (EM). - Ensure regulatory activities align with business goals and meet regional requirements. - Provide regulatory input on product development strategies to optimize approval timelines. 2. In-Licensing & Out-Licensing Support: - Conduct regulatory due diligence for in-licensing opportunities, including the assessment of regulatory documentation, market authorization status, and compliance risks. - Collaborate with the business development and legal teams to provide regulatory input during in-licensing negotiations, ensuring the regulatory feasibility of potential assets. - Support out-licensing efforts by preparing regulatory documentation and ensuring products meet the requirements of potential partners in target markets. - Evaluate potential regulatory hurdles for in-licensed products and propose strategies to ensure smooth registration and commercialization in emerging markets and Europe. 3. Regulatory Submissions & Approvals: - Lead preparation, review, and submission of regulatory documents to health authorities in Europe and Emerging Markets, including Marketing Authorization Applications (MAAs), New Drug Applications (NDAs), and Variations. - Manage communication with regulatory agencies, including EMA (European Medicines Agency), national authorities, and regulatory bodies in emerging markets such as ANVISA, TGA, SFDA, etc. - Ensure timely responses to Health Authority questions and ensure product registration and maintenance is completed on time. 4. Compliance & Regulatory Oversight: - Ensure regulatory compliance in line with EU and emerging market regulations, guidelines, and policies. - Monitor regulatory developments, including new regulations, guidelines, and scientific trends in the EU and Emerging Markets. - Collaborate with Quality Assurance to support GMP inspections and audits by regulatory authorities. 5. Cross-functional Collaboration: - Work closely with R&D, Clinical, Commercial, and Manufacturing teams to ensure regulatory input into product development and commercialization strategies. - Provide critical regulatory support to business development teams in evaluating partnership and licensing opportunities. - Participate in cross-functional project teams to support the development and execution of in- and out-licensing deals from a regulatory perspective. 6. Team Leadership & Management: - Lead and manage a team of regulatory professionals across Europe and Emerging Markets. - Provide mentorship, training, and career development for regulatory staff. - Oversee external consultants and vendors providing regulatory support for specific projects. 7. Regulatory Intelligence: - Maintain up-to-date knowledge of regulatory requirements, trends, and changes in the EU and Emerging Markets. - Ensure the organization is informed about new regulatory developments that may impact product registration, market access, or licensing opportunities. 8. Risk Management: - Identify regulatory risks and propose mitigation strategies to the executive team. - Engage in early regulatory consultations with agencies to de-risk product development, approval, and licensing processes. 9. Lifecycle Management: - Oversee regulatory activities for marketed products, including handling variations, renewals, and product discontinuations. - Ensure regulatory documentation is updated and maintained throughout the product's lifecycle.

Delhi NCR

Regulatory Head - Europe & Emerging Markets 

Job Description for Regulatory Head - Europe & Emerging Markets  in Sphinx Sommet Solutions LLP in  Delhi NCR for (15-30) years of experience. Apply Now!