Vice President. Regulatory Affairs
Remote based position – Travel monthly to EU HQ (Average 2 days monthly)
Locations Suitable: UK, Netherlands, Sweden, Ireland or Switzerland
Employment Type: Full time. Employed.
Therapeutic backgrounds associated and required: Neurology, CNS, Psychiatry
Key Experience Regulatory relative required:
* 6+ Years in a leadership position in industry
* 15+ Years combined industry Regulatory experience – Working to Director / Snr Director or VP levelling
* Preferable experience or combined experience of 4+ years working in Biotech/Biopharma or Innovative growth Pharma for Neurological, CNS or Psychiatry relative rare/orphan indications
* FDA – Direct experience working with FDA and related IND and NDA submissions and annual reports
* FDA – Proven success and direct hands on/ownership experience in implementation, management and execution of Regulatory strategies for FDA approved products, plus management of all associated evidential processes through submissions, including holds, study data and evidence presentation
* EU – Experience in managing and driving forward the implementation of CTA / MAA submissions in Europe
* Team Management – Ideally 3+ years of direct line management experience of associated Regulatory team members
Our client is an advancing Biotech with ongoing developments in studies that are aimed at transforming treatments of relative Neurological disorders.
As part of ongoing progressions, they now seek an experienced Regulatory leader with solid and proven experience working ideally in a combination of unmet need rare/orphan indications plus Combi type products associated to Neurological conditions and/or CNS and Psychiatry relative.
The position is a unique opportunity to be part of an evolving and innovative Biotech group, working closely aligned with the senior executive leadership group, and taking ownership for the onward Regulatory strategies – With a high focus initially on FDA evolvements and relative strategies for advancements.
The ideal candidate will have an autonomous and high performing success driven attitude to ‘making things happen’ and be able to take a lead and drive direction for the associated Regulatory tasks for both North America advancements through FDA direct interactions, and in future onwards through EU/EMEA.
The position will require a visionary blend of both strategic lead and influence, plus abilities to drive forward the operational execution.
The position has the advantage of being operational on a remote basis, and the successful candidate can be a resident in any of the following countries: United Kingdom, Netherlands, Sweden, Ireland or Switzerland.
It is likely that on average at least 2 days monthly would be required to work with the leadership group and associated teams at the European based HQ.
Qualifications & Experience Required:
* Resident and eligible to work in either: United Kingdom, Netherlands, Sweden, Ireland or Switzerland
* Advanced medical/scientific degree
* Direct experience either industry or research combination relative in either: Neurology, CNS, Depression or Psychiatric disorders
* Direct industry experience: Circa 15+ Years, including 6+ years at leadership level
* Direct experience working with FDA - Essential
* Team management experience – Direct line reporting: 3+ years
* Experience working in developing and growth organisations ideally sought, combined with abilities to be flexible, and work in an adaptable and autonomous manner in a growing organisation, with a strong collaborative and team ethic approach to getting things done
* Ability to travel as required, both locally and nationally, or globally as required
Further details will be available on application, should your skills align and present potential interest to our client.
To Apply
In the first instance please send your CV and any relevant support details for consideration.