Regulatory Affairs Director

Our client is a young, exciting publicly listed clinical-stage company dedicated to transforming the lives of patients in its therapy areas. With its novel and proprietary drug products and current clinical development programs, our client aims to provide improved treatments for patients with increased remission rates, faster onset of action, durable effects, and improved tolerability and convenience. This requires experience and a track record of successful development in complex and innovative areas, and an excitement for creating something new and groundbreaking.

To help achieve their mission, the role will provide the rare opportunity for a high-performing, innovative thinker to play a role in transforming the treatment of neuropsychiatric disorders by supporting the development of next-generation mental health therapies from concept to reality. For this reason, we’re looking for a Director of Regulatory Affairs to work closely with the existing regulatory team, internal and external experts, and contribute to the successful execution of our pivotal clinical program and commercialization.

• Manage in-house preparation and execution of clinical trial applications, ensuring compliance with regulatory requirements and company timelines.
• Oversee submissions made by regulatory vendors on the sponsor’s behalf to ensure a high standard of quality is maintained.
• Provide RA review of essential clinical study/submission documents such as clinical protocols, IMPDs, IBs, CSRs and informed consent forms.
• Provide hands-on guidance and oversight of future global marketing authorization applications, in line with regulatory guidelines.
• Act as RA representative on product development teams as assigned and provide RA guidance and oversight in line with corporate objectives.
• Interface with regulatory agencies on aspects of clinical studies as appropriate with oversight of RA management.
• Work with the technical development and device regulatory team as required in the development of drug-device combination products, in line with current regulatory requirements.
• Maintain RA submission and correspondence archives in compliance with document retention policies.
• Proactively identify changes in the global regulatory landscape that may impact activities, provide RA intelligence to internal stakeholders and assist in preparing the organization for any internal adaptation that may be required.
• Author, review and update RA SOPs as needed, with emphasis on clinical regulatory processes.
• Maintain links with external regulatory network, proactively identify training/development needs and identify opportunities to further regulatory knowledge in clinical areas.
• Maintain a professional and credible image with regulatory agencies, consultants, vendors and colleagues.

Person Spec

• RA experience in biotech companies of at least 8 years, with a strong focus on clinical development including practical oversight of CTAs as a sponsor and hands-on management of in-house clinical trial preparations.
• Experience with international (US, EU and UK) regulatory dossier preparation (e.g., CTA/MAA or IND/NDA), including eCTD requirements.
• Direct experience of CTIS is beneficial.
• Experience of participation/leading regulatory interactions with key agencies, including US FDA and EMA.
• Experience of the development of drug-device combination products, particularly from a clinical regulatory perspective.
• Knowledge of global regulatory guidelines, GxPs, local regulations and industry best practices.
• Ability to understand and interpret clinical data/information and its practical application in regulatory contexts.
• Experience of technical/regulatory writing (e.g., briefing books, responses to questions, applications for early access schemes, paediatric plans etc).
• Experience of working with multi-located cross-functional teams including in an outsourcing model using regulatory vendors.
• Proficient in pertinent software such as Microsoft Office Suite and Adobe Acrobat.
• Experience across a range of therapeutic areas; experience in psychiatry and/or neurology is a benefit.
• Experience of the development of scheduled drugs is a benefit.
• Bachelor’s or advanced degree (MS, PhD or MD) in Life Sciences/Health-Related Sciences.

Knowledge and Abilities

• Strong attention to detail with exceptionally high standards for document and submission quality.
• Excellent written/oral communication skills.
• Team oriented and flexible.
• Able to manage conflicting priorities.
• The attitude and ability to be effective in a lean, small company environment in early-stage research biotech business in pre-revenue/profits phase.
• Ability to embrace and drive change across functions.
• Energetic and enthusiastic.
• An entrepreneurial, business-oriented mindset / strong fit with the team; willing to “roll their sleeves up”.