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For Companies At a Glance
- Tasks: Lead regulatory strategies for innovative mental health treatments and collaborate with top-tier professionals.
- Company: Dynamic biotech firm focused on transforming lives through groundbreaking therapies.
- Benefits: Remote work flexibility, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in mental health while working with cutting-edge biotech innovations.
- Qualifications: 8+ years in Regulatory Affairs with experience in Biotech/Biopharma and FDA interactions.
- Other info: Join a passionate team dedicated to advancing neuropsychiatric treatments.
The predicted salary is between 36000 - 60000 £ per year.
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.
Director of Regulatory Affairs employer: Morgan Prestwich - Life Science & Healthcare Executive Search
Contact Detail:
Morgan Prestwich - Life Science & Healthcare Executive Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and regulatory affairs space. Attend industry events or webinars, and don’t be shy about introducing yourself. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews! Research the company and their recent projects, especially in neuropsychiatric treatments. We want you to show them you’re not just another candidate, but someone who’s genuinely excited about their mission and can contribute to their goals.
✨Tip Number 3
Practice your pitch! You’ll want to clearly articulate your experience with FDA interactions and regulatory submissions. We suggest rehearsing with a friend or in front of a mirror to ensure you come across as confident and knowledgeable.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always on the lookout for passionate candidates who are ready to make a difference in the biotech world.
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in Regulatory Affairs, especially in Biotech. We want to see how your background aligns with the specific requirements mentioned in the job description.
Showcase Relevant Experience: When writing your application, emphasise your direct interactions with FDA and any experience with regulatory submissions. This is crucial for us to see your fit for the role.
Be Clear and Concise: Keep your application clear and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and achievements.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity.
How to prepare for a job interview at Morgan Prestwich - Life Science & Healthcare Executive Search
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of FDA and EMA regulations, especially those related to INDs, NDAs, and CTAs. Be ready to discuss your past experiences with these submissions and how they relate to the role.
✨Show Your Hands-On Experience
This role is all about being hands-on, so prepare examples from your previous positions where you took initiative in regulatory affairs. Highlight any direct interactions you've had with regulatory agencies and how you navigated those processes.
✨Demonstrate Team Collaboration
Since this position involves working closely with the VP of Regulatory Affairs, be prepared to talk about your experience in team settings. Share specific instances where you collaborated effectively to achieve regulatory goals.
✨Bring Your Entrepreneurial Spirit
The ideal candidate has an entrepreneurial mindset, so think of ways to showcase your innovative thinking. Prepare to discuss how you've led projects or initiatives that made a significant impact in your previous roles.
