Senior Regulatory Affairs Manager, Development

Senior Regulatory Affairs Manager, Development, Start-up, Strategic Focus

We are looking for an experienced regulatory affairs professional who can take the lead on a late phase pharmaceutical product in the run up to an MAA. This is for a relatively small pharma company, hence, great for someone who wants to take a leading role with autonomy and responsibility, free of the shackles of big pharma. As well as being an opportunity to make a name for yourself working on a very promising product, it also offers a chance to help develop on the future pipeline of the company. Please contact me should you be interested.

Key Responsibilities:

• Help lead meetings with health authorities
• Project management and strategic responsibilities for a leading product
• Commercial input with alliance partners and project teams
• Input towards submissions combined with work in collaboration with CMOs, CRO and contractors

Key Requirements:

• Over 7 years experience in regulatory affairs for Rx products
• Experience in EU or FDA submissions in pre-approval
• Fluency in English
• Based in the EU or Switzerland

For a confidential discussion about regulatory affairs, or to apply, then send your CV to m.beedle@nonstop-recruitment.com or call me, Matt Beedle, Regulatory Affairs Consultant for Switzerland on +41435 080817 .For regular job updates and market information please join the Switzerland regulatory affairs linked-in group. https://www.linkedin.com/groups/4550988

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Specialties: *Switzerland Regulatory Affairs Market with a focus on German speakers *Biologics EU-wide *Module 3, e-CTD, Chemistry Manufacturing and Controls(CMC) *ATMP, ATP, AT, Advanced Therapeutics, World Wide *Recruitment at all levels including associate, manager, senior manager, associate director, director, global director, senior director and vice president. *SwissMedic candidates