Director, Regulatory Affairs - United Kingdom
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- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to target tumors.
- The Director of EU Regulatory Affairs will provide regulatory leadership in support of the development and commercial programmes at our company.
- This includes the development and implementation of regulatory strategies, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.
- This person will represent the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the regulatory affairs department.
- The Director may work remotely but must be available to travel up to 20% of the time.
- This position will report directly to the VP of Regulatory Affairs.
- Provide strategic European regulatory leadership to project teams.Develop and implement regulatory strategies for development pipeline and commercial products.
- Lead the planning, preparation and delivery of regulatory submissions throughout the product's life cycle from an EU regional perspective, including but not limited to clinical trial applications, GMO applications, pediatric investigation plans, orphan designation applications, briefing documents and MAAs.
- Ensures the business needs for our company's products are met by anticipating, identifying, prioritizing and mitigating regulatory risks, while ensuring compliance with European regulatory requirements
- Lead negotiations with European Regulatory Agencies.
- Lead and develop regulatory guidance and training on internal policies and procedures
- Ensure compliant regulatory review and approval of all advertising and promotional materials for launched products.
- Collaborate with other departments to advise of changes in regulatory guidance which may impact the business
- Contribute to the preparation of new regulatory guidance, and communicate the impact of new regulatory requirements or changes in legislation across the organization.
- Responsible for liaising with other R&D and commercial functions
- Manage relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met.
- Provide regulatory due diligence assessments in cooperation with Business Development as required.
Skills and Competencies
- Must be able and willing to work in a high-visibility, fast-paced environment.
- Must be flexible, detail-oriented, and possess good analytical and problem-solving skills.
- Has strong blend of being a team player, but also able to work on own initiative and prepared to take ownership and responsibility for his/her actions.
- Excellent verbal and written communication skills.
- Results focused and able to work under pressure and meet deadlines.
- Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally.
- Adaptable and self-motivated, able to prioritize effectively with good problem-solving and planning abilities.
Education and Experience Requirements
- University Degree in Science or related discipline. A higher degree would be desirable.
- Extensive experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry, or experience at a health authority.
- Ideally a combined mix of large company best practices and smaller company adaptability and experience.
- Sound knowledge and experience of Regulatory Affairs and associated requirements, plus pharmaceutical industry experience of clinical trial and drug development work with a track record of successful drug development through product approval in Europe.
- Thorough knowledge of the European drug development and approval process for ATMP products.
- Experience in interfacing with Regulatory Authorities in Europe and an excellent track record of building relationships with and influencing Regulatory Agencies.
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.