Adaptimmune
Senior Director, Global Regulatory Affairs CMC
Adaptimmune, Phila, Pennsylvania, United States, 19117
Adaptimmune is a fully integrated commercial-stage cell therapy company, designed and built from the ground up with UK- and U.S.-based biotechnology hub locations. In the U.S., locations are in Cambridge, MA and Philadelphia, PA. In the UK, locations are in Oxford and Stevenage. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
primary Responsibilities
The Senior Director of Global Regulatory Affairs CMC is responsible for leading the CMC sub-team within Global Regulatory Affairs (Head of Reg CMC). This role provides CMC regulatory affairs leadership and oversight in support of the product portfolio, including but not limited to CMC regulatory strategies, CMC regulatory development plans and risk assessments, critical issue management, and advice and management of CMC-related Health Authority interactions. This role will be responsible for the line-management, including training & mentorship, assignment of projects, and oversight of members of the Reg CMC team. Critical to this role are strong technical, CMC regulatory strategy, and leadership skills.
Key Responsibilities
Provides regulatory leadership and oversight to the CMC sub-team within Global Regulatory AffairsAssures development and execution of robust CMC regulatory strategies for the Adaptimmune portfolio, including development, registration, and life-cycle management stages.Supervises the work of Reg CMC subteam members and manages external vendors (consultants/contractors) supporting the Reg CMC activitiesOversees CMC regulatory staff and participates in skill-development, coaching, and performance feedback of CMC regulatory staffProvides guidance on the scientific/technical requirements for CMC and CGMP related submissionsReviews and/or approves CMC and CGMP related submission documents to assure compliance with regulatory standards and scientific/technical requirements and ensure their appropriateness for use in regulatory submissions.Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, advises appropriate level of risk and mitigations to senior management for significant issues, as required.Develops and maintains collaborative relationships with internal and external stakeholders.Actively engages with industry organizations (eg: ARM, DIA, RAPS, etc) to drive cross-industry best practices and support evolving global regulatory CMC guidanceDrives adherence at enterprise level to CMC regulatory requirements and guidelines.Performs CMC regulatory intelligence activities - monitor regulation changes and competitor trends/strategy; Analyzes trends and evaluates the impact of changes in Regulatory requirements for CMC related submissions; communicates changes to appropriate areas to ensure compliance with required standardsRepresents the company at appropriate regulatory and scientific conferences.Participates in due diligence activities on potential licensing, acquisition, or collaboration opportunitiesDirects the authoring, review, and finalization of CMC Regulatory documentation.Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)Oversees change controls assessments and provides assessment of regulatory impact and plans global amendmentsQualifications & Experience
Required
Bachelor's Degree in a scientific discipline is requiredMinimum of 10-15 years of relevant pharmaceutical/biotech experience including minimum of 5 years of Global Regulatory Affairs CMC experience in the cell and gene therapy spaceExperience with pharmaceutical development of drug substance and drug products, including analytical characterization and manufacturing process developmentProven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market support teams.Successful track record of providing robust regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidanceExperience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs)Ability to effectively liaise with Regulatory Agencies, having served as lead in successful Agency interactions related to CMC submissions and product development meetings; international experience preferredKnowledge of relevant domestic and global regulations and guidanceAbility to work effectively in cross-functional and matrixed teamsProven leadership and management experience of regulatory staffExtensive knowledge in ICH, FDA, EMA and international regulations/guidelinesDesirable
Advanced degree in scientific discipline is strongly preferredExperience with BLAs/NDAs/MAAs is strongly preferred
other requirements
Travel as required for internal and external meetings, including health authority meetings.
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
primary Responsibilities
The Senior Director of Global Regulatory Affairs CMC is responsible for leading the CMC sub-team within Global Regulatory Affairs (Head of Reg CMC). This role provides CMC regulatory affairs leadership and oversight in support of the product portfolio, including but not limited to CMC regulatory strategies, CMC regulatory development plans and risk assessments, critical issue management, and advice and management of CMC-related Health Authority interactions. This role will be responsible for the line-management, including training & mentorship, assignment of projects, and oversight of members of the Reg CMC team. Critical to this role are strong technical, CMC regulatory strategy, and leadership skills.
Key Responsibilities
Provides regulatory leadership and oversight to the CMC sub-team within Global Regulatory AffairsAssures development and execution of robust CMC regulatory strategies for the Adaptimmune portfolio, including development, registration, and life-cycle management stages.Supervises the work of Reg CMC subteam members and manages external vendors (consultants/contractors) supporting the Reg CMC activitiesOversees CMC regulatory staff and participates in skill-development, coaching, and performance feedback of CMC regulatory staffProvides guidance on the scientific/technical requirements for CMC and CGMP related submissionsReviews and/or approves CMC and CGMP related submission documents to assure compliance with regulatory standards and scientific/technical requirements and ensure their appropriateness for use in regulatory submissions.Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, advises appropriate level of risk and mitigations to senior management for significant issues, as required.Develops and maintains collaborative relationships with internal and external stakeholders.Actively engages with industry organizations (eg: ARM, DIA, RAPS, etc) to drive cross-industry best practices and support evolving global regulatory CMC guidanceDrives adherence at enterprise level to CMC regulatory requirements and guidelines.Performs CMC regulatory intelligence activities - monitor regulation changes and competitor trends/strategy; Analyzes trends and evaluates the impact of changes in Regulatory requirements for CMC related submissions; communicates changes to appropriate areas to ensure compliance with required standardsRepresents the company at appropriate regulatory and scientific conferences.Participates in due diligence activities on potential licensing, acquisition, or collaboration opportunitiesDirects the authoring, review, and finalization of CMC Regulatory documentation.Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)Oversees change controls assessments and provides assessment of regulatory impact and plans global amendmentsQualifications & Experience
Required
Bachelor's Degree in a scientific discipline is requiredMinimum of 10-15 years of relevant pharmaceutical/biotech experience including minimum of 5 years of Global Regulatory Affairs CMC experience in the cell and gene therapy spaceExperience with pharmaceutical development of drug substance and drug products, including analytical characterization and manufacturing process developmentProven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market support teams.Successful track record of providing robust regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidanceExperience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs)Ability to effectively liaise with Regulatory Agencies, having served as lead in successful Agency interactions related to CMC submissions and product development meetings; international experience preferredKnowledge of relevant domestic and global regulations and guidanceAbility to work effectively in cross-functional and matrixed teamsProven leadership and management experience of regulatory staffExtensive knowledge in ICH, FDA, EMA and international regulations/guidelinesDesirable
Advanced degree in scientific discipline is strongly preferredExperience with BLAs/NDAs/MAAs is strongly preferred
other requirements
Travel as required for internal and external meetings, including health authority meetings.
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.