Director of Regulatory Affairs

Director/Senior Director. Regulatory Affairs

Locations Suitable: UK – Nationwide or Ireland

Remote based position – Travel to EU HQ (Average 1-2 days monthly)

Employment Type: Full time. Employed.

Overview

Our client is an innovative and growing Biotech, with a driven purpose and mission to transform the lives of patients through innovative treatments for associated Neurological and Psychiatric disorders – With high focus on relative treatments for depression.

This is an exciting, challenging, and rewarding opportunity for an innovative Regulatory Affairs professional, who has aligned experience in Biotech, plus proven Regulatory credentials working on relative high unmet need indications – Involving direct FDA interactions and wider European agency associations.

This Regulatory Director/Senior Director opportunity has been created due to upscale and further support needs within the existing group and will be working in close collaboration with the VP of Regulatory Affairs.

You will be supporting advancements for the treatment of pivotal Neuropsychiatric disorders – Spearheading evolvements for potential next-generation mental health therapies. The role will be highly ‘hands on’ and will help to define the regulatory roadmap for the current ongoing clinical development programme.

Your background will ideally include several years industry experience relative in Regulatory Affairs at Director level, plus a combination of experience working directly in innovative Biotech/Biopharma. A key requirement includes associated experience that includes direct FDA Regulatory interactions.

Key Experience Regulatory relative desired:

• 8+ Years in Regulatory Affairs – Industry Relative (3+ Years recent/to date - working in Biotech/Biopharma) with associated focus on Clinical Development
• Experience in preparation of regulatory submissions for FDA, EMA and other international agencies
• Combined experience including: INDs, NDA’s, CTAs, MAA’s. Amendments, EU scientific advice, FDA meetings + Regulatory Affairs review of essential study/submission documents - clinical protocols, IBs, CSRs
• Regulatory CMC activities experience - Highly desirable
• CTIS experience - Advantageous
• Combined or singular experience of 3+ years working in Biotech/Biopharma or Innovative growth Pharma
• Ideal therapeutic associations including - Neurological, CNS, Psychiatry or Depressive Disorders
• Experience working across drug-device combination products – Advantageous
• Technical/regulatory writing abilities – Such as: Briefing books, responses to questions, applications for early access schemes
• Associated experience or knowledge of global marketing authorization applications
• FDA – Direct experience working with FDA and related IND and NDA submissions and associated report inputs and associated Regulatory strategies
• A resilient attitude, strong team ethics and team collaborative attributes are ideally sought – Combined with strong organisational skills and a flexible and adaptable approach to work
• An entrepreneurial mindset with abilities to lead direction and ‘roll up the sleeves’ – Combined with energy and enthusiasm to ‘make a difference’

Degree levels Considered: Bachelor’s degree. MS, PhD, MD

The ideal candidate will have an autonomous and high performing success driven attitude to ‘making things happen’ and will demonstrate credibility to take a self-lead and drive direction, with the support of the Regulatory VP and associated teams for the Regulatory tasks assigned for - North America advancements in connection with FDA interactions, and ongoing with EU/EMEA.

The position has the advantage of being operational on a remote basis in either the UK (Nationwide) or Ireland. Ideally being accessible and agreeable to 1-2 days a month to 6 weeks on average in the European HQ.

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.