Director, Global Regulatory Affairs CMC

• Develops, executes and oversees the preparation of major global registrational submissions
• Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement
• Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters
• Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required
• Fosters constructive working relationships when interacting with internal and/or external colleagues
• Providing strategic input into change control evaluation - as required
• ensures and / or enhances regulatory compliance
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success
• Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards
• When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation and provides tactical regulatory guidance to product teams in line with global regulatory strategies
• Proactively identifies regulatory CMC risks, ensuring timely communication with line management
• Leads assigned global regulatory submissions through product lifecycle
• Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations
• Works effectively across a complex matrix environment
• Supports development of strategies, tools, and trainings to further the GRA CMC roadmap
• Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required
• 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA
• Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered
• Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams
• Analyze issues with attention to detail
• Ability to assess alternative approaches
• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines
• Able to deal with issues of critical importance with minimal oversight
• Exercises good judgment in elevating and communicating actual or potential issues to line management
• Applies direction taken by the company
• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork
• Intentionally promotes an inclusive culture
• Applies given prioritization framework with limited support
• Excellent written and oral communication skills required
• Exercises good judgement in elevating and communicating actual or potential issues to line management

Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred

• Short-term and/ or long-term incentives
• medical, dental, vision insurance
• 401(k) plan and company match
• short-term and long-term disability coverage
• basic life insurance
• tuition reimbursement program
• paid volunteer time off
• company holidays
• well-being benefits
• up to 80 hours of sick time per calendar year
• new hires are eligible to accrue up to 120 hours of paid vacation