£Competitive | US based, virtual role
Boyds is a dynamic and growing organisation that provides specialist consultancy services to a wide range of clients, and we specialize in supporting the development of advanced therapy medicinal products (ATMPs), small molecules and biologics across a wide range of therapeutic areas to support the development of new medicines for patient benefit.
We are currently looking for a Regulatory Affairs Director or Associate Director (depending on experience) to join our award-winning regulatory team and support the company’s further growth in the US, and can offer you excellent opportunities for your own growth and development.
In this role, you will provide support to the Boyds’ Regulatory Affairs team across a dynamic range of regulatory projects and therapeutic areas as needed to support the group’s regulatory services and activities. Client-facing role acting as the regulatory project lead for submissions to the FDA, EMA, MHRA, and other. Direct liaison with the FDA and other health authorities.
- As a subject matter expert, lead on complex and multifactorial projects for clients, providing strategic regulatory advice based on regulations and guidelines to facilitate project development based on client needs, coordinating internal cross-functional resources where needed across regions. Activities will include gap analyses, strategic advice on filing routes, timing, regulatory authority interactions, risk/benefit presentation, pediatric development, orphan drug designation and PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation [BTD/RMAT] applications and all applicable expedited review pathways.
- Highlight and mitigate potential risks to timelines, budget and deliverables for clients.
- Preparation (authoring/reviewing) of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications and investigational new drug applications, and marketing applications.
- Lead regulatory agency interactions and negotiations to ensure client goals are met.
- Act as a backup for the head of the US office for all US business activities, US Agent and other as assigned.
- Internal quality control activities as required including working along with the Boyds quality team to ensure ongoing compliance.
- Input and support for team development, growth, and structure, including Boyds’ approach to quality management and project oversight as it pertains to regulatory affairs.
- Resolve internal/external project issues as needed, with escalation to senior management when appropriate.
- Involvement in business development as assigned, potentially including drafting of cost proposals and networking activities. Domestic travel opportunities for group or client meetings; international travel once yearly for all-company meeting.
The successful candidate will have:
- BS in life sciences; advanced degree preferred.
- Minimum of 6 years of experience in regulatory affairs with a focus in early-stage projects: nonclinical, clinical, through phase 3.
- Strong experience and current knowledge of FDA regulations and guidances; international experience preferred.
- Previous successful IND, NDA/BLA, and related submissions.
- Cell and gene therapy experience highly preferred.
- Effective manager and communicator versed in interactions with health authorities, clients/partners, direct reports, and cross functional teams.
- Independent contributor able to thrive in a virtual environment with a global team and client base.
In return, we can offer an opportunity to work with a team with significant experience in developing groundbreaking ATMP (including gene therapies), biological and small molecule therapies for a range of conditions, many of which are in the rare disease and oncology therapy areas. We are a growing, friendly, efficient and effective team and can help you to grow your future career in a professional and varied environment.
Boyds is a fast-growing consultancy business providing a range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Headquartered in the UK with offices in Cheshire, Cambridgeshire, Dublin and Pennsylvania, Boyds has an international client base comprising of early-stage life science and medical device companies as well as Universities.
Boyds has earned a reputation for its work in advanced therapies and in 2018, the company was awarded the prestigious Queen’s Award for Enterprise, International Trade for outstanding short-term growth in overseas sales.
Please note: This role is available from April 2023.
If you are interested in joining us, please send your CV and a short description of why you enjoy working in regulatory affairs and the difference you believe you could make for our clients to email@example.com.
No agencies please.