Director, Regulatory Affairs
Immunocore

Conshohocken, Pennsylvania

Posted in IT


Job Info


About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key ResponsibilitiesThe 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 scientific and tactical strategy development, 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, MHRA, and other local Health Authorities providing an excellent opportunity to develop worldwide regulatory experience.

The ideal candidate will have experience gained in biologics and the preparation of late-stage regulatory filings, with regulatory tactical leadership skills and implementation. This role will also require someone who can work within a highly innovative, agile, and entrepreneurial environment and is able to lead the regulatory strategy through effective collaboration and be able to deliver and work well under pressure as this will be a high-profile role.

Key Responsibilities:

To provide regulatory leadership and support to cross functional development project teams to jointly achieve strategic objectives.
To be responsible for the US and ex-US regulatory activities associated with the project teams.
Develop regulatory scientific, and tactical strategic plans, and target labelling to support product development of products.
Provide leadership for the development and writing of regulatory submission documents, including 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/MMAs, 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, anti-infectives, autoimmune diseases, and biologics.
Contribute to the establishment and development of procedures and working practices commensurate with the requirements of a company in late-stage development and commercialization.
Overseeing regulatory review of clinical trial labelling and CMC submissions for regulatory compliance, in conjunction 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 compliant with all regulations and guidance.
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.

Experience & Knowledge:

Essential:
Solid track record in drug development and leadership within a dynamic project team(s).
Solid scientific background with evidence of emerging ability to develop regulatory scientific strategies.
Strong understanding of global regulatory requirements to be able to form functional regulatory strategies.
Excellent knowledge of US regulatory requirements and extensive 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. Submission of at least 1 NME BLA/NDA is highly desirable.
Experience in preparing for and conducting Health Authority Meetings (FDA required). Ability to develop and maintain an ongoing liaison relationship with FDA and other global Health Authorities.
Demonstrate ability to be agile to accommodate changing priorities.
Must have proven leadership, excellent communication and interpersonal skills.

Preferred:
Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs. Submission of at least 1 NME BLA/NDA is highly desirable.
Experience in preparing and conducting Health Authority Meetings (FDA required). Ability to develop and maintain an ongoing liaison relationship with FDA and other global Health Authorities.

Qualifications:
Advanced degree preferred - M.S., PharmD, Ph.D., or M.D. with 5-10 years' experience or BS with 8-12 years' experience.



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