Regulatory Strategist
Job ResponsibilitiesInternational - Reg Strategy Manager, Sr Manager (LATAM)
The Regulatory Affairs Manager will be lead and support submissions in Latin American Markets for MAAs and life-cycle management procedures and will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices.
Key Duties & Responsibilities
- Drive and coordinate regulatory strategy and local regulatory activities in Latin America and provide regional regulatory expertise for geographical expansion.
- Track all Health Authorities' requests and relevant new local regulations and forward to relevant GRA contact.
- Maintain current knowledge of local requirements and anticipate, assess and communicate changes to Regulatory Senior Management in a timely manner.
- Lead cross functional Vertex team to prepare submission activities from the planning phase through to submission and review, including preparing responses to questions.
- Act as support to submission lead by preparing timelines and creating submission binders in Veeva and ensuring submission and correspondence files are up to date
- Provide local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner
- Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as regulatory requirements, local labelling guidance, CTD and GMPs.
- Ensure all work is compliant with regulatory requirements and company policies and procedures
Regulatory Experience & Education Requirements
- Relevant industry experience in regulatory affairs in Latin America and understanding of current trends in local and regional requirements.
- Recognized as a knowledgeable resource for regulatory advice by other departments
- Experience of interacting with Regulatory Authorities
- Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and external parties (mainly submission partners)
- Bachelor's degree in Pharmaceutical Sciences
- Advanced written and spoken English and knowledge of Spanish and Portuguese will be considered an advantage
Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
