Senior Team Leader - Regulatory Affairs, Emerging markets

Job Description

Regulatory Strategy Development: Develop and execute regulatory strategies for launching products in Emerging markets (SEA, GCC, CIS & Latam), considering regional nuances and regulatory requirements. Stay updated on regulatory changes and assess their impact on product registrations and compliance strategies. Regulatory Submissions and Approvals: Lead the preparation, submission, and management of regulatory dossiers and applications to obtain timely approvals for product launches. Coordinate responses to regulatory queries and requests for additional information to expedite approval processes. Cross-functional Collaboration: Collaborate closely with internal and external stakeholders such as R&D, Quality Assurance, Legal, and Marketing to ensure regulatory requirements are integrated into product development and launch plans. Provide regulatory guidance and support to teams to resolve issues and mitigate risks. Compliance and Risk Management: Monitor regulatory compliance throughout the product lifecycle, including post-market surveillance and reporting obligations. Assess regulatory risks and develop mitigation strategies to ensure business continuity and compliance with regulations. Relationship Management: Establish and nurture strong relationships with regulatory authorities and agencies and customers in Emerging Markets. Represent the organization in regulatory meetings, negotiations, and discussions to influence regulatory outcomes beneficial to the company. Regulatory Intelligence and Training: Stay abreast of emerging trends, guidelines, and best practices in regulatory affairs relevant to Emerging Markets. Conduct training sessions for internal teams to enhance awareness and understanding of regulatory requirements and processes.