Responsible and accountable for regulatory CMC strategies. RA CMC lead for the assigned program(s) on Regulatory, Product Technical Development, and Global Project teams throughout clinical development and commercial launch. Ensures global strategies are successfully executed for assigned cell therapy products.
Demonstrates high level of leadership and comprehensive understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.
Demonstrates comprehensive understanding of CMC regulatory requirements for a biologic, vaccine, gene therapy and/or cell therapy.
Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
Understand complex technical content such as various methods for ex vivo modification of cells in order to develop robust global regulatory CMC strategies for cell therapy programs.
Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development and global marketing applications.
Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.
Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
Lead team members that define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
Manages and develops staff, if required, including staff professional development and project oversight accountability.
Represents Takeda RA CMC in Health Authority meetings and leads preparation activities for meetings with Health Authorities on CMC related matters.
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provides solutions to prevent recurrence of issues.
Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.
Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
Evaluates change proposals for global regulatory impact and plans global variations and amendments.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up and/or regulatory registration of products is required.
Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope. Proven ability to liaise with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred.
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
Demonstrates leadership, problem-solving ability, flexibility and values teamwork.
Demonstrated ability to work well within a matrix structure in a complex environment.
Exercises good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
Excellent written and oral communication skills required.
Active participation in Agency/Industry groups/forums preferred.