Description
The Technical Regulatory Program Director is an integral part of our Cell & Gene Therapies (CGT) organization, dedicated to driving the development and strategy for cell-based gene therapies and somatic cell therapies.
The Opportunity:
This individual contributor position is at the forefront of shaping global regulatory strategies and is accountable for working with internal and external collaborators to enable the development and delivery of innovative cell and gene therapies to patients worldwide. In this opportunity, you will develop and drive global regulatory strategies, while maintaining compliance and alignment. You will also ensure effective communication with senior leadership regarding project status, submission risks, and the impact on regulatory strategies and timelines. Additional accountabilities include:
- Contributing to the development of innovative cell-based therapies within the CGT product portfolio, which encompass a variety of ATMP modalities
- Driving the regulatory strategy for cellular therapy programs, ensuring alignment across functions
- Accountability for submitting high-quality CMC regulatory documents to health authorities, providing clear rationales for meeting regulatory expectations; coordinate health authority meetings and generation of meeting packages
- Collaborating with regulatory policy colleagues to comment on new ATMP global guidelines
- Contributing to regulatory excellence by finding opportunities, mitigating risks, and supporting continuous improvement
- Ensuring compliant, accurate, and timely completion of regulatory deliverables while supporting clear decision-making within CMC regulatory teams
- Collaborating with cross-functional colleagues in Analytical Development, Process Development, Quality, R&D, Project Management, among other functions
- Leading regulatory aspects of change control, health authority inspections, and appropriate communication to teams
Requirements
Who you are:
- You possess a postgraduate degree AND 7 or more years of experience in the biopharmaceutical industry (CMC, Regulatory, Quality, Cell Banking, Analytical Development, or Manufacturing)
- You have demonstrated experience leading strategic regulatory activities for development from early stages through market launch
- You are proficient with control strategies for cellular therapies including donor eligibility requirements and comparability assessments
- Technical knowledge: You have experience with CAR T-cell or other genetically modified cells and/or you have experience with somatic cell therapies such as iPSC- or hESC-derived products. You have knowledge of ATMP-relevant regulations of major regions (e.g. ICH, FDA, EMA). You are proficient with regulatory filings and strategies for cell and/or gene therapies. Experience with cell differentiation and expansion or with genetic modification of cells (e.g. viral vector-based, genome editing) is a plus. You are familiar with a wide range of topics of relevance to cellular therapies and stay abreast of an evolving global regulatory landscape (e.g. WHO, ICH, FDA, EMA, PMDA, etc.)
- Business acumen: You are experienced in drug development and commercialization, and you are familiar with the multidisciplinary functions involved in drug development (including non-clinical and clinical). You are able to work in an area where the regulatory expectations may not be well defined. You also possess strategic agility and proficiency in business tools and risk management principles. You drive for continuous improvement, and are flexible in ways of working.
- Collaboration and leadership: You have demonstrated the ability to work effectively in a cross functional team environment while keeping management informed and consulted as needed. You take a pragmatic approach and are able to “think outside of the box”. You are able to effectively prioritize and manage your own work.
- Influencing and negotiation skills: You drive optimum results through skillful collaboration with cross functional team members without formal authority and are adept at identifying solutions that will meet the needs of all parties involved.
- Communication: You have excellent verbal and written communication skills.
Relocation benefits are approved for this posting.
The expected salary range for this position based on the primary location of California is $151,600.00 - $281,500.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
