International Product Partner
International Product Partner
Switzerland, Basel-Town, Basel
International Product Partner tasks and responsibilities are:
- Prepares the Regulatory Strategy for the emerging and regional affiliates in alignment with the global strategy and provides to the Global Regulatory Leader and PDR management the gap analysis from affiliates business expectations and/or Health Authorities expectations.
- Leads the interaction with the affiliates to share early product knowledge and assess their local needs.
- Prepares regulatory filing plans for emerging and regional affiliates that are integrated into the global development plan.
- Coordinates with the Clinical Trials management team the dispatch and oversight of clinical trial applications for select key countries and is responsible to answer health authority questions.
- Supports the Global Regulatory Leader on cross-functional teams in representing the emerging and regional affiliate’s strategies at the Regulatory Affairs Functional Team (RAFT)
- Coordinates and manages the filing application preparation for clinical and preclinical aspects for the emerging and regional affiliates.
- Is responsible to answer questions from health authorities in the emerging and regional markets for applications under their responsibility.
- Travel 10-20%
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
- University Degree, preferably in life science discipline with minimum of 5years experience in Regulatory Affairs
- Proven successful experience in International regulatory affairs
- Knowledge and experience of global regulatory processes
- Excellent communication and negotiation skills
- Ability to manage multiple and complex tasks independently and at the same time ability to work effectively to share responsibility as a team member
- Leadership: provide strategic input, set milestones, allocate responsibility and monitor the progress towards results
- Commitment to performance measures of time, cost and quality
Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.
Roche is an equal opportunity employer.
- Location Switzerland, Basel-Town, Basel
- Function Regulatory Affairs
- Subfunction Drug Regulatory Affairs
- Schedule Full-time
- Job level Individual Contributor
- Job type Regular Employee
- Division Roche Pharmaceuticals
- Date 2016/09/29
- Job-ID 2569025509
Get in touch
Mathieu Vetter+41 61 688 41 00
You could also like these jobs
Pasante de Dirección TécnicaArgentina, Buenos AiresDrug Regulatory Affairs ManagerMorocco, Center, CasablancaRegulatory Affairs ManagerUnited States, Arizona, Tucson