GRA CMC Director

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Job Description – Director GRA CMC Marketed Products Development (MPD) Lead

Join Takeda as Director, Global Regulatory Affairs CMC Marketed Products Development (MPD) Lead, where you are accountable for developing and executing on GRA CMC strategies for lifecycle management.  You develop and execute on global strategies across the existing portfolio, lead a team, and ensure their effectiveness in a complex matrix environment.  Reporting to the Head of GRA CMC for MPD, CMC Sourcing and Due Diligence, you partner closely across the organization to influence, enhance prioritization, and strengthen communication and decision making processes.

How you will contribute:

• Independently manage regulatory submissions for assigned compounds for global marketing applications, and post-approval life cycle activities.
• Evaluate change proposals for global regulatory impact and plan global variations and amendments.
• Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
• Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and review content for conformance with established requirement.
• Ensures project team, 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.  Provide solutions to prevent recurrence of issues.
• Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
• Stay up to date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share experience with others to support their development.
• Maintain constructive relations with essential colleagues, e.g., colleagues within Takeda, Alliance Partners, and Health Authority representatives.

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
• 10+ 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 active pharmaceutical ingredient/drug substances, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products is required.
• Expert in developing alternate strategies based on guidance/regulations.
• Expert in liaising 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; application of knowledge to all areas of life-cycle management.
• Ability 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.
• Able to provide sound strategic advice and enable critical decisions under ambiguity.
• Demonstrate leadership, problem-solving ability, flexibility, and values teamwork.
• Demonstrate strategic enterprise thinking, with the ability to influence at all levels in a complex matrix environment.
• Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
• Good judgement in elevating and communicating actual or potential issues to line management.
• Builds and maintains a team environment that inspires and enables people to move the organization forward.
• Expert in CTD authoring and/or review skills throughout the product lifecycle, with a solid understanding of global submission complexities.

• Willingness to travel to various meetings, including overnight trips.
• Requires approximately up to 10-30% travel.