Regulatory Affairs Lead - Zurich
Jocelyn Blackham is recruiting for a Regulatory Affairs Lead to join a leading company in the pharmaceutical industry at their site based in Zurich on a contract basis until October 2020.
The main purpose of the role will be to:
- Lead the local Swiss overall regulatory strategy working in collaboration with the Regional and Global Regulatory Leads to successfully deliver the product development and life cycle management plans in accordance with agreed business priorities. Also responsible for ensuring the compliance of registered products with local laws and requirements.
- Serve as the key liaison between the company and the local Health Authority and also the Industry Associations.
- Lead a highly effective team who strives for a performance-based culture and delivers operational excellence working in a cross-functional environment within R&D and the Commercial business based on the company values.
- As a team leader, coach and facilitate the professional development of the team will be a high priority.
Further responsibilities will include:
- Taking accountability for local Regulatory Affairs (RA) input into submission and launch strategy, aligned with commercial plan, and for timely submission & approval of marketing authorisation applications, variations and renewals. Maintain relevant knowledge of company's pipeline.
- Ensuring RA support for local product launches and early access programs. Collaborate with Market Access and Health Economics teams on the evidence generation and value proposition strategy including preparation of the Pricing and Reimbursement Dossier (HTA).
- Completing due diligence for locally in-licensed products from RA perspective including support for MA Transfers.
- Acting as the primary contact for regulatory health authorities (HA) in national procedures and post-approval. Build relationships with HA, understand their internal workings, maintain open communication channels and respond with urgency and accuracy to Health Authority requests. Active involvement and participation at Industry Associations where possible.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Knowledge of the national and EU pharmaceutical legislation
- Understanding of Drug Development and Marketing processes and requirements
- Previous experience in Pharmaceutical Regulatory Affairs, including QA/QP (FvP) and PV experience
- Fluent written & spoken German, French & English / Italian as additional national language is a plus
- In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry
This is an excellent opportunity to join a global pharmaceutical company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference 47571 in all correspondence.