Associate Director leading global regulatory strategy for Telix’s radiopharmaceutical PSMA portfolio. Supporting worldwide submissions, approvals, lifecycle management, and health - authority interactions.
About the role
- Regulatory Strategist guiding Latin American drug submissions and lifecycle management for Syneos Health’s life sciences services. Providing regional expertise, coordinating authorities, and leading cross-functional submission teams.
Responsibilities
- Lead and support submissions in Latin American markets for MAAs and lifecycle management procedures
- Provide local regulatory expertise as a member of the Global Regulatory Affairs team
- Drive and coordinate regulatory strategy and local regulatory activities in Latin America
- Provide regional regulatory expertise for geographical expansion
- Track Health Authority requests and relevant new local regulations
- Maintain knowledge of local requirements and communicate regulatory changes to senior management
- Lead cross-functional teams through submission planning, preparation, submission, and review
- Prepare responses to regulatory questions
- Prepare timelines and create submission binders in Veeva
- Keep submission and correspondence files up to date
- Act as local expert for regulatory queries from medical, supply chain, and other functions
- Ensure compliance with regulatory requirements and company policies and procedures
Requirements
- Relevant industry experience in regulatory affairs in Latin America
- Understanding of current trends in local and regional regulatory requirements
- Knowledgeable resource for regulatory advice
- Experience interacting with Regulatory Authorities
- Ability to facilitate interactions with International Regulatory Affairs, internal departments, and external parties/submission partners
- Bachelor's degree in Pharmaceutical Sciences
- Advanced written and spoken English
- Knowledge of Spanish and Portuguese considered an advantage
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate
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