Global Director for Regulatory Affairs, Strategic Overview

Global Regulatory Affairs Director

Excellent opportunity to work with one of the biggest upcoming names in the Pharma industry in a vibrant and growing regulatory affairs team. We are looking for people with strong EU regulatory affairs experience who have been involved in strategy and program management for drug approvals in Europe. In addition to managing key approvals for EU, this person will be involved in a number of global project teams and have significant input towards future regulatory strategies. One key point to mention about this company is that they already have established products while also having a good pipeline. Because of this, they offer both a level of security, while also giving the chance to grow and have autonomy like that within a start-up.

Primary Position Responsibilities:

• Involvement in health authority and scientific advice meetings
• Leadership of regulatory submissions
• Involvement in numerous project teams
• Close collaboration with vendors and CROs
• Management of a small team
• Coverage for products in pre and post approval

Requirements:

• Experience of MAA submissions covering both pre and post approval for drug products in Europe
• Experience in leading submissions and being involved in development teams
• Involvement in strategic RA teams
• Life science degree
• Fluency in English

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

I am a specialist head hunter(recruiter) for regulatory affairs in the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on the Swiss regulatory affairs market as well as ATMP(Advanced Therapeutics) and biological regulatory professionals world wide. Please refer to ch.linkedin.com/in/regulatoryaffairsswitzerland for references.

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