Associate Director, Global Regulatory Affairs CMC

3316 Takeda Development Center Americas•Boston, MA

11h•Hybrid

About The Position

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization. The Associate Director will develop and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products with minimal supervision. This role contributes to the team’s delivery of critical functions by serving as a RA CMC member on the Global Regulatory CMC team and potentially acting as the delegate for the GRA CMC Product Lead at various project teams. The position requires a strong foundational understanding of global RA CMC regulations and guidelines, with the ability to apply this knowledge to projects to enhance regulatory success and compliance. The role also involves drawing from prior experience, precedents, and regulatory intelligence beyond regulations, utilizing strong analytical or process understanding to develop robust submissions, and fostering constructive relationships with internal and external colleagues, including Alliance Partners. The Associate Director will also communicate and negotiate with Health Authorities and apply GRA CMC knowledge to overcome challenges during development and commercialization.

Requirements

BS/BA Degree in a Scientific Discipline.
10+ years of overall biopharmaceutical/device industry experience.
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.
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 judgment 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.

Nice To Haves

Advanced Degree (M.S., Ph.D., etc.) preferred.
Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.

Responsibilities

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 requirements.
Represents Takeda RA CMC in Health Authority meetings and supports CMC preparation activities for meetings with Health Authorities on CMC related matters (with supervision).
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.
Ensures regulatory compliance with HA regulations as a GRA CMC member.
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 judgment and communicating professionally and timely.
Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.
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 when in a GRA CMC Product Team lead role.
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.