Location: Cambridge or North West Office (some flexibility for home working can be negotiated if needed)
Remuneration: Competitive + Bonus, Pension & Benefits
This company's regulatory team is looking to hire an enthusiastic and motivated regulatory affairs professional to join and support the future growth of their team, working across a range of product types and therapeutic indications in both the EU and US.
In this role, you will use your existing skills and knowledge to support and, over time, lead projects from candidate selection to nonclinical and clinical development and to marketing authorisation and beyond. This role, which offers an invaluable opportunity to grow your skill set in a thriving and varied environment, will largely consist of the following activities:
- Preparation and submission of initial clinical trial applications (CTA’s), investigational new drug applications and amendments
- Support with the preparation and submission of regulatory documents such as orphan drug designation applications, scientific advice briefing documents, paediatric investigation/study plans, PRIority MEdicines (PRIME)/ Breakthrough Therapy Designation (BTD) and marketing authorisation applications
- Provide support for input into and development of the regulatory strategy for projects, taking into account existing guidelines and available measures to facilitate regulatory input, incentives and early market access (e.g. gap analyses, advice on filing routes, timings, regulatory authority interactions, paediatric development, orphan drug designation and PRIME/BTD applications)
- Support for regulatory agency interactions/negotiations to ensure goals are met
- Provide support to all ongoing projects and business activities as required, including mentoring of other members of the team as appropriate
- Maintain up to date regulatory knowledge and contribute to the company’s regulatory intelligence function.
The hiring company can offer an opportunity to work with a team with significant experience in developing ground-breaking advanced therapy medicinal products (ATMPs), biologicals and small molecule therapies for a range of conditions, many of which are rare diseases. They are a small, friendly, efficient and effective team and can help you to grow your future career in a professional and varied environment.
- Regulatory Affairs experience, with a minimum of a B.Sc. in a life sciences subject (a higher degree would be a distinct advantage)
- Experience in writing of regulatory documents for the EU; an understanding of US submissions would be advantageous
- Ideally CTA regulatory experience
- Good organisational skills and the ability to work to deadlines across multiple projects
- Excellent communication skills (written and verbal)
- Ability to demonstrate initiative and attention to detail
- Must demonstrate integrity, high standards, appropriate flexibility and a willingness to learn and develop