Assistant Director

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.

Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.



Position Description:

Incumbent will be the contact between the company and the FDA for their portfolios, and will be responsible for developing and maintaining the closest possible long term relationships with key agency officers. Candidate will work closely with Global Project Teams, Therapeutic Groups, GDDCs and commercial groups. Candidate will share with their colleagues learnings from their FDA interactions, so that the resulting accumulation of shared knowledge will lead to improved overall regulatory strategies and greater global success. Similarly, candidate will use their own expertise in regulatory activities to coach others in the department, thus helping to raise the general level of expertise.

Duties/Responsibilties
1. Liaison with FDA for projects
2. Provide regulatory leadership to project teams
3. Notify and seek input from management about critical regulatory issues
4. Share regulatory experience within department and across company


To Apply Visit Sanofi Aventis

Qualifications:

Knowledge/Skills
Candidate must have an in-depth understanding of the drug development process in the environment of a major pharmaceutical enterprise operating through a global matrix

Formal Education/Experience
MD or PhD preferred (MS required)- Regulatory Liaison experience with FDA, EMEA and/or other regulatory bodies- Position offers high levels of personal accountability, candidate will be self-motivated and a resourceful individual, who see opportunity in ambiguity and have the vision and drive to achieve outstanding results through collaboration and teamwork. - Excels at identifying novel strategies in complex situations, and will have outstanding communication skills and interpersonal capabilities.