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- Tasks: Lead regulatory strategies for innovative mental health treatments in a dynamic biotech environment.
- Company: Join a pioneering biotech firm dedicated to transforming lives through cutting-edge therapies.
- Benefits: Remote work flexibility, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on mental health advancements while collaborating with top industry professionals.
- Qualifications: 8+ years in Regulatory Affairs with experience in Biotech/Biopharma and FDA interactions.
- Other info: Work remotely from the UK or Ireland with occasional travel to the EU HQ.
The predicted salary is between 43200 - 72000 £ 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. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of FDA and EMA regulations. Be ready to discuss your past experiences with INDs, NDAs, and clinical development. Show them you’re not just a fit on paper but also a passionate candidate who knows their stuff!
✨Tip Number 3
Don’t forget to showcase your entrepreneurial mindset! In interviews, share examples of how you’ve led projects or initiatives in the past. Highlight your ability to roll up your sleeves and make things happen – that’s what they’re looking for in a Director role!
✨Tip Number 4
Apply through our website for a smoother process! It’s super easy and ensures your application gets the attention it deserves. Plus, we love seeing candidates who take the initiative to apply directly with us!
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 relevant regulatory submissions you've handled. This will help us see your hands-on experience in action!
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 quickly.
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.
✨Showcase Your Biotech Experience
Highlight your experience in the Biotech or Biopharma industry, particularly any hands-on roles you've had. Prepare examples of how you've contributed to regulatory strategies or clinical development programmes in your previous positions.
✨Demonstrate Team Collaboration
This role requires strong team ethics and collaboration. Think of specific instances where you've worked closely with cross-functional teams, especially in a regulatory context, and be ready to share those stories.
✨Be Ready for Questions
Prepare for questions about your approach to regulatory challenges and how you handle direct interactions with agencies like the FDA. Consider potential scenarios and how you would navigate them, showcasing your problem-solving skills.
