| 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.
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| 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 |
| CV Email | Application by email |
