Senior Manager, Global Regulatory Affairs CMC

3316 Takeda Development Center Americas•Boston, MA

2d•Hybrid

About The Position

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. The Senior Manager, Global Regulatory Affairs CMC will lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products with some supervision. This role may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout the clinical development and commercial lifecycle. The position requires a strong foundational understanding of global RA CMC regulations and guidelines, and the ability to apply this understanding to projects to enhance the probability of regulatory success and compliance. The role also involves drawing from precedents and other regulatory intelligence beyond regulations, and possessing strong analytical or process understanding to enable the development of robust and accurate submissions. Developing constructive relationships and proactively communicating issues to key internal and external colleagues, including Alliance Partners, is also a key aspect of this role.

Requirements

BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
6+ 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.
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 some 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.
Exercises good judgment in elevating and communicating actual or potential issues to line management.

Responsibilities

With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s).
Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
Ability to understand the overall product strategy and anticipate future challenges.
With supervision, supports 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 with some supervision.
As a RA CMC member, ensures and/or enhances regulatory compliance.
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner.