Senior Regulatory Affairs Manager
Debiopharm Group™ (Debiopharm) is a Swiss-based biopharmaceutical group of five companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investment management. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for worldwide marketing and sales.
For our Regulatory Affairs, Market Intelligence & Market Access Department based in Lausanne, we are looking for a Senior Regulatory Affairs Manager.
Reporting to the Director Regulatory Affairs, you contribute as project team member to the strategic and operational aspects of regulatory affairs, within a matrix organization.
Your main responsibilities
- Contribution to the definition of the regulatory strategy for the development and registration of compounds in Europe and the USA;
- Preparation and filing of regulatory documentation in relationship with the drug development process (IND, CTA, PIP, orphan drug...) and the registration process (MRP/DCP, centralised procedure, BLA/NDA);
- Preparation and review of new applications, variations and answers to Health Authorities’ questions;
- Conduct of the regulatory due diligence of new compounds evaluated in view of their potential licensing-in;
- As a member of project teams, providing input on regulatory aspects in relationship with the preclinical and clinical development phases.
- Degree in Pharmacy, Medicine or Life Sciences, preferably at PhD level;
- 5-10 years Regulatory Affairs experience in the EU and/or the US;
- Significant experience in the development of oncology, haematology and/or immunotherapeutic drugs;
- Experience in the drug development regulatory aspects in Asia would constitute an advantage;
- Excellent team-working and interpersonal skills, with the flexibility to actively contribute within multidisciplinary and multicultural teams;
- A high degree of self-motivation, coupled with a positive and proactive approach;
- Computer literacy is essential;
- Excellent written and communication skills in English and French.
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision;
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry;
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application using this form.
For more information: www.debiopharm.com.