Head of Regulatory Affairs (Interim / Permanent)
Our Client is an ambitious drug development company headquartered in North America, publicly quoted with a headcount of c. 120 employees. European operations are centered in Switzerland.The company has two marketed products approved in Europe (and other territories), both of which are in the cardiovascular area. Other non-CV products are however in development as is a drug/device combination product for which regulatory submissions are planned over the coming months.
The need has emerged for a top-quality Interim Head of Regulatory Affairs who will be responsible for defining global regulatory strategies and submissions in support of new and existing marketing authorizations.
Alignment with the company’s business objectives and its partners around the world, coordination with key stakeholders is imperative.
The Head of Regulatory Affairs develops and manages regulatory plans for complex projects including new marketing authorizations, or the maintenance of existing licences. This role provides regulatory affairs leadership to a small internal team, as well as managing third party regulatory operations providers, as well as supporting regulatory functions from the company’s partners.
This interim assignment is initially expected to be of 4-6 months duration, and is likely to demand between 3 and 5 days per week. The successful candidate can be based anywhere in Western Europe. Whilst the majority of the work can be conducted from a home base, a small amount of international travel will be required.
For the right candidate, there is a real possibility of subsequently transitioning into the permanent role.
It is likely that the successful candidate will have…
- A Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related life sciences.
- A strong clinical foundation.
- Experience with 10+ years of Regulatory Affairs experience in a biopharmaceutical company and 5+ years in a management role with an emphasis on support to post-marketing activities including marketing, medical affairs, life cycle management, labeling line extensions, manufacturing, testing and distribution of ethical pharmaceutical products. Additional experience in a smaller pharma company is a plus.
- A track record of successful interactions and approvals with EMA and international markets including Eastern Europe, Russia, North/South/Central America and Asia-Pacific for small molecules.
- A strong working knowledge of pharmaceutical regulations and processes internationally and an excellent track record in building effective relationships with regulatory authorities and distributors.
- Experience in all components of regulatory submissions including CMC, non-clinical, and clinical documentation.
- Submission experience in cardiovascular and immunological targeted therapeutics would be an asset but not essential, as would device regulatory experience.
This is an excellent and exciting opportunity in an ambitious and fast-growing company. The contribution to be made will be highly visible and of critical importance.
If this opportunity is a good fit with your own areas of experience and expertise, please make contact with Geoff Newman (Interea) as soon as possible.
> Click here to view other assignments
