Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Global Regulatory Affairs CMC team, you will be responsible and accountable for regulatory CMC development, registration and post-approval strategies, and a typical day will include: 

Objective / Purpose

• 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. 

• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. 

Accountabilities

• 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.   

• 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.  

• 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 and/or enhances regulatory compliance.

• If in a line manager role, provides project and administrative oversight, mentorship and guidance to direct reports, develops talent, fosters DEI principles and ensures open communication.

Education & Competencies (Technical and Behavioral)

• 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. 

• 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 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 

• Exercises good judgement in elevating and communicating actual or potential issues to line management. 

• Excellent written and oral communication skills required.  

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com