- Provides program leadership and develops CMC regulatory strategy to global vaccine programs in various stages of development. Strong focus on analytical, manufacturing, and facilities compliance.
- Represents the vaccine regulatory affairs team on cross-function Takeda Vaccines teams (commercial, clinical development, delivery, quality, etc) to ensure that data are identified, obtained and effectively presented for the registration of products world-wide.
- Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization. Conduct routine regulatory surveillance and coordinate comments on new/changing regulations globally.
- Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
- Leads planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed
- Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization
- Leads regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development and the commercial life cycle
- Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
- Represents Takeda RAV CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
- Interacts directly with international Health Authorities, as required. Participates in and/or leads agency meetings
- Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
- 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
- May serve as direct/matrix manager of up to 4 RAV CMC staff, depending on project. Responsible for prioritization of workload and professional development of staff
- Other duties as needed
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred.
- 10 + years Regulatory CMC experience (vaccines or biologics experience required). Alternatively 5+ years Regulatory CMC experience combined with 5+ years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance).
- Proven ability to liaise with Regulatory Agencies in Agency Interactions and product development meetings, global experience preferred. Demonstrated track record for successful interactions with FDA and preferably other global health authorities related to CMC submissions.
- Understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development, registration, and post-market support. Proven ability to provide strategic regulatory guidance to teams. Experience with managing BLA/MAA content and format required.
- Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrated leadership, problem-solving ability, flexibility and teamwork.
- Experience with process development, analytical characterization, process scale-up and/or regulatory registration of biological drug substances or drug products (including sterile parenteral dosage forms) is required.
- Exercises good judgement in elevating and communicating actual or potential regulatory risks to teams and line management.
- Excellent written and oral communication skills required.
- Active participation in Agency/Industry groups/forums preferred.
- Manual dexterity to operate office equipment (i.e. computers, phones, etc.)
- Up to 30%, as needed . Some international travel required.
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