Associate Director/ Director of Regulatory Affairs
We’re on a mission to transform the lives of people with some of the world’s most challenging diseases. Using our soluble TCR platform that produce both ImmTAC® and ImmTAV® molecules, we have potential to deliver life changing medicine that can target and destroy cancer and viral infections, respectively. This is your opportunity to join us as a regulatory project team leader and be part of the next phase of our journey. You will be working on ground-breaking oncology drugs and a hepatitis B anti-infective drug that has potential to have a real impact on patients.
- To provide regulatory leadership and support to cross functional development project teams to jointly achieve strategic objectives.
- To be responsible for the US regulatory activities associated with the project teams.
- Provide input into regulatory strategies and target labelling to support development of products, along with leadership for implementation of agreed strategies.
- Provide leadership for the development and writing of regulatory submission documents, ex. Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.
- You will manage, prepare, co-ordinate and be responsible for the submission of the documentation supporting regulatory submissions to the US and wider international regulatory authorities, in support of CTA/INDs, BLAs/MAAs, CTA safety reports and updates, along with all other regulatory submissions.
- To be the center of excellence (point of contact) of all regulatory requirements and guidelines globally, in particular within the US, and monitoring the regulatory environment for oncology and biologics.
- Contribute to the establishment and development of procedures and working practices commensurate with the requirements of a company in late stage development.
- Overseeing regulatory review of clinical trial labelling and CMC submissions for regulatory compliance, in junctions with the Director of Regulatory CMC.
- Will need to demonstrate a high level of professionalism, efficiency and leaderships within the team whilst demonstrating critical thinking, effective problem solving and a strong knowledge of regulatory strategies and alignment with all necessary compliance.
- To be responsible for reviewing and ensuring the quality of detailed scientific and technical information are presented clearly and supporting conclusions are adequately evidenced by the data.
- This role may include some occasional overtime based on work priorities, potentially over weekend.
- The Associate Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore’s development programs to include: regulatory strategy input and implementation, IND development/submission/maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. The role will also involve interacting with our global sites, both in-house and outsourced. Establishing a successful relationship with the FDA, along with being responsible for overseeing submissions to the EMA, and MHRA providing a fantastic and unique opportunity to develop worldwide regulatory experience.
- The ideal candidate will have experience gained in biologics and the preparation of late stage regulatory fillings supported by excellent leadership skills. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to provide input into the regulatory strategy through effective collaboration and be able to deliver and work well under pressure as this will be a high-profile role.
- Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 3-8 years’ experience. BS with 5-10 years’ experience.
- Associate Director to Director title commensurate with experience
- Solid track record in drug development and leadership within a dynamic project team(s)
- Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development. Global experience desirable. Experience in working cross functionally and globally within Regulatory Affairs.
- Experience in supporting global clinical studies
- Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs. Contribution to part of the submission of at least 1 NME BLA/NDA is highly desirable, but not required.
- Experience in preparing, and conducting Health Authority Meetings (FDA) desirable, but not required. Ability to develop and maintain an ongoing liaison relationship with FDA and other global Health Authorities and the health authority project manager level.
- Demonstrate ability to be agile to accommodate changing priorities
- Must have proven leadership, excellent communication and interpersonal skills.