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- Tasks: Lead regulatory strategies for innovative cell and gene therapy products across Europe.
- Company: Join a pioneering biotech firm focused on advanced therapy medicinal products.
- Benefits: Enjoy competitive salary, flexible working options, and opportunities for professional growth.
- Why this job: Be at the forefront of groundbreaking therapies and make a real impact in healthcare.
- Qualifications: 8+ years in biotech/pharma with strong regulatory affairs experience required.
- Other info: Collaborate with global teams and shape the future of medicine.
The predicted salary is between 72000 - 108000 £ per year.
As our regulatory team continues to grow, we have an exciting opportunity for an experienced Director of Regulatory Affairs to join us. This role will focus on pioneering cell and gene therapy products across Europe. The successful candidate will be part of a global regulatory affairs team, overseeing the preparation, submission, and review of regulatory applications for health authorities across Europe and beyond.
This position provides a unique opportunity to work on Advanced Therapy Medicinal Products (ATMPs) in key therapeutic areas. The role involves collaborating with cross-functional teams, shaping regulatory strategies, and contributing to the advancement of a cutting-edge therapeutic portfolio.
Key Responsibilities- Develop and implement regulatory strategies in collaboration with internal teams.
- Assess regulatory risks and provide solutions to mitigate potential challenges.
- Act as the primary contact with regulatory agencies, leading key interactions.
- Plan, coordinate, prepare, and submit major regulatory applications (e.g., PIP, Orphan Designation, Variations).
- Manage the approval process and regulatory maintenance throughout the product lifecycle.
- Lead the development and timely submission of responses to regulatory agency inquiries.
- Organize and execute regulatory agency meetings, including preparing scientific advice packages.
- Provide regulatory leadership for clinical studies, including overseeing documentation and submission planning.
- Author and review key regulatory submission documents in collaboration with internal and external teams.
- Ensure compliance with ATMP regulations while keeping up to date with evolving international requirements.
- Monitor the competitive landscape and provide regulatory insights to project and clinical teams.
- Support cross-functional teams, including research, manufacturing, and clinical operations, ensuring high-quality regulatory submissions.
- Ensure that all regulatory activities align with internal compliance policies and industry regulations.
- Adhere to company health and safety standards.
- E – At least 8 years of experience in the biotech or pharmaceutical industry, with a minimum of 5 years in regulatory affairs, including post-marketing experience.
- E – Strong knowledge of gene therapy regulations and international guidelines related to ATMPs.
- E – Proven experience leading major regulatory submissions, including MAA, PIP, Orphan Designation, and major variations.
- E – Expertise in regulatory project management, including coordination of multiple submissions.
- E – Strong writing skills for scientific and regulatory documentation.
- E – Experience in leading scientific advice meetings and engagements with regulatory agencies.
- E – Proficiency with regulatory information management tools (e.g., Veeva).
- E – Excellent communication skills and the ability to work collaboratively across teams in different locations.
- E – Strong organizational skills, with the ability to prioritize tasks and meet deadlines.
- P – Experience with Clinical Trial Authorisation (CTA) applications in Europe, with US IND experience considered an asset.
- P – Familiarity with regulatory submissions related to environmental risk assessments/GMO requirements for gene therapy products.
- P – Knowledge of regulatory requirements for medical devices, including IDEs and CE certification.
- E – A Master’s degree or equivalent in pharmacy or life sciences, with a strong pharmaceutical or medical background.
Director of Regulatory Affairs employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with Advanced Therapy Medicinal Products (ATMPs). Attend industry conferences and seminars to meet potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines related to gene therapy in Europe. Understanding the nuances of these regulations will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare for potential interviews by practising how you would handle key regulatory scenarios, such as leading a major submission or addressing regulatory agency inquiries. Being able to articulate your thought process and strategies will set you apart from other candidates.
✨Tip Number 4
Showcase your leadership skills by highlighting any past experiences where you successfully led cross-functional teams in regulatory projects. This will illustrate your ability to collaborate effectively and manage complex submissions, which is crucial for this role.
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, particularly in gene therapy and ATMPs. Use specific examples of your past roles and achievements that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for regulatory affairs and the biotech industry. Mention how your experience aligns with the company's goals and the specific role.
Highlight Key Skills: Emphasise your strong writing skills and experience with regulatory submissions. Include any specific tools you are proficient in, such as Veeva, and mention your ability to lead scientific advice meetings.
Showcase Collaborative Experience: Since the role involves working with cross-functional teams, provide examples of how you've successfully collaborated with different departments in previous positions. This will demonstrate your ability to work effectively in a team-oriented environment.
How to prepare for a job interview at Skills Alliance
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in regulatory affairs, especially your knowledge of gene therapy regulations and ATMPs. Be prepared to discuss specific examples of major regulatory submissions you've led, such as MAAs or PIPs.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working with various teams, share instances where you've successfully collaborated with cross-functional teams. Emphasise your ability to communicate effectively and lead discussions with different stakeholders.
✨Prepare for Regulatory Agency Interactions
Given that you'll be the primary contact with regulatory agencies, practice articulating how you would handle key interactions. Discuss your experience in leading scientific advice meetings and how you prepare for these engagements.
✨Stay Updated on Evolving Regulations
Show your commitment to staying informed about the latest developments in regulatory requirements. Mention any recent changes in ATMP regulations or guidelines that you are aware of, and how you adapt strategies accordingly.
