Associate Director, Global Regulatory Affairs CMC

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets.

With minimal supervision, you will define CMC content, develop regulatory strategies, collaborate with cross-functional teams and Health Authorities, and ensure regulatory compliance with Takeda procedures and global requirements.

Qualifications

• Regulatory CMC knowledge
• Experience with regulatory submissions
• Strong communication and collaboration skills

Responsibilities

• Lead regulatory CMC submissions for investigational, registration and post-approval programs
• Serve as RA CMC member on Global Regulatory CMC team
• Interact with Health Authorities and internal/external partners
• Define CMC content requirements for regulatory submissions
• Ensure conformance with Takeda procedures and global regulatory standards

Job description

Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:

• With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
• RA CMC member on the Global Regulatory CMC team.
• May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
• Has a strong and deep foundational understanding of global RA CMC regulations and guidelines.
• Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance.
• Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.
• Strong analytical or process understanding that enables the development of robust and accurate submissions.
• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
• Successfully communicates and negotiates with Health Authorities - directly and indirectly.
• Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization.
• With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy.
• Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
• With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters.
• Interacts directly with international Health Authorities on administrative procedural topics, as required.
• Fosters constructive working relationships when interacting with internal and/or external colleagues.
• Evaluates change proposals for global regulatory impact.
• As a GRA CMC member, ensures regulatory compliance with HA regulations.
• Assures conformance with Takeda controlled procedures and GRA CMC best practices.
• 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.
• 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 (e.g., technical regulatory strategy documents, storyboards, risk