Manager, Regulatory Affairs Vaccines, Mexico

Manager Regulatory Affairs Vaccines

Ref	USOT30575
Company Description	Our client is one of the largest worldwide company dedicated to human vaccines.
Job Description	Responsible for the interface between regulatory R&D and the clinical & regulatory structure in the Americas for clinical and licensure phases primarily of the dengue vaccine. All activities are associated essentially with the dengue NV project, there may be a small percentage of involvement with other products. Liaison with local clinical groups , regulatory groups and health authorities to : collect required information on Phase 2 & 3 trial requirements , coordination and supply of the necessary regulatory documents in close liaison with HQ RA, strategic interface with HAs when blockages. Review of clinical protocols, amendments, preparation of Q&A, review of Q&A from HQ. US interface with CBER, meetings, strategic proposals.
Skill Required	Scientific degree , Masters or PhD Pharmacist, engineer Minimum of 5 years experience in regulatory field - preferably in vaccines, sterile injectables, biotech products Good level of English and Spanish Negotiation skills, cultural awareness for LatAm, capacity to manage multiple countries/interfaces in a high profile project, capacity to share and collaborate with local teams as well as HQ
Benefits	competitive
Country	Mexico
City, region
Discipline	Other
Sector	Pharmaceutical and Biotechnology