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Manager, Biologics and Synthetic Drugs Regulatory Strategy
hace 1 semana
Our Company Overview
We are a global biotechnology company that applies scientific expertise to develop transformative medicines for patients with significant unmet medical need. Since our founding, we have developed a diverse pipeline of commercial, clinical, and preclinical candidates with well-understood biology.
About the PositionThis role is responsible for managing and implementing regulatory strategies, preparing and executing regulatory submissions, and maintaining relationships with regulatory authorities in LATAM countries.
Main Responsibilities- Collaborate with key functional areas to ensure regulatory strategies align with commercial objectives.
- Prepare and submit marketing applications, post-marketing maintenance, and clinical updates for biologics and synthetic drugs in LATAM countries.
- Develop regulatory filing strategies and identify risks for listed countries.
- Serve as primary liaison with regulatory authorities and interface on behalf of BioMarin.
- Bachelor's degree in life sciences or related field.
- At least 5 years of biotechnology or pharmaceutical industry experience, including at least 3 years in Regulatory Affairs.
- Demonstrated knowledge and understanding of the regulatory environment in North LATAM.
