By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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.

How you will contribute:

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

• Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead. Assigned products include genetically modified cell therapies and other unique modalities

• Represents, contributes and influences Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development

• Demonstrate exceptional leadership and expert understanding of GRA CMC regulations and guidelines.  Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from vast prior experience, precedents and other regulatory intelligence beyond regulations.  Adept analytical and process understanding that enables the development of robust and accurate submissions

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

• Successfully communicates and negotiates with International Health Authorities proven by track record – directly and indirectly. 

• Utlizes profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges that arise during development and commercialization.  

• Coaches and develops people and teams, recruits and rewards to retain talent. Supports culture of high performance and trust, assures that the required level of knowledge and skills is available and identifies competency gaps. Establishes and implements effective development plans.

Accountabilities:

• Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.  

• Combines extensive knowledge of science and regulatory to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.  Proficiently leads overall product strategy with anticipation to future challenges.

• Represents or supervises representation at Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters.

• Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required.

• Fosters constructive and influential working relationships when interacting with internal and/or external colleagues.  

• Providing strategic input into change control evaluation with a focus on consistent best practice and efficiencies.

• As a GRA 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 judgement and communicating in a professional and timely manner.   Acts as an advisor and liaison to senior management.

• As a member of the modality management team, actively contributes to the strategy of the modality functional team and GRA-CMC 

• Leads a group of regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according to agreed business priorities.

• Provides project and administrative oversight to support team’s goals according to agreed timelines, provides coaching, and knowledge sharing. Establishes and implements effective development plans.  to direct reports, develops talent, fosters diversity, leveraging individual strengths for team success (DEI principles) and builds trust through open communication.

• 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.

• Proactively identifies regulatory CMC risks and opportunities, ensuring timely communication of recommended scientific and risk-based approach with line management. 

• Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.

• Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations. 

• Masterfully lead within a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to drive efficiency and excellence, ensure effective strategies are implemented and project execution is on target. 

• Key thought leader to drive development of strategies, tools, and trainings to further the GRA CMC roadmap. 

• Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in effective and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.  

Minimum Requirements/Qualifications:

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S), with Ph.D. preferred.  

• 15+ years of seasoned biopharmaceutical/device industry experience or with a regulatory agency, while leading major submissions during LCM, development – including preparation of NDA/NLA/MAA. Equivalent industry experience with direct technical/product development experience such as Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.  People leadership experience (5+ years) required.

• Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and post-market support.    Abreast of industry insights and regulatory trends to drive organizational evolution.

• 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 and scientifically justify 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 independently

• Exercises excellent judgment in elevating and communicating actual or potential issues to line management.   

• Understands who is responsible for different decisions, drives and escalates as necessary. 

• Applies directions taken by the company, leading with agility through evolving landscapes. 

• Intentionally promotes an inclusive culture, leveraging individual strengths for team success.

• Develops and drives prioritization framework, managing shifting priorities and tight deadlines.

• Exceptional skills in written and oral communication. 

• Demonstrates excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork.  

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

#LI-Hybrid

#LI-AA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$208,200.00 - $327,140.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.