Associate Director, Global Regulatory Affairs CMC

Takeda • Boston, MA

11h • Hybrid

About The Position

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.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
• 10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered).
• 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.
• 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 supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
• Understands who is responsible for different decisions and escalates as necessary.
• Applies decisions taken by the company.
• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
• Intentionally promotes an inclusive culture.
• Applies the 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.

Responsibilities

• 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 assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies.
• Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities.
• Supports and/ or leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
• Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target.
• Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.

Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level