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Job Description

About the role:

We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.

The Strategist (Sr Manager) works in a highly highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant Takeda R&D functions to provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally.

How you will contribute:

The Strategist, Global Regulatory Affairs CMC, PDT BU is responsible and accountable for:

• Defining, coordinating and implementing global CMC regulatory strategies for product-specific development and life-cycle activities

• Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets.

• The role liaises directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters. Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval.

• Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives.

• Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals.

• Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.

• Identifies and recommends the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations.

• Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant stakeholders or functions in line with Takeda’s operating model with the purpose to obtain, maintain and extend Takeda PDT BU product registrations in global markets. Provides proactive guidance and regulatory strategies to support PDT product teams.

• Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs.

• In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams.

• In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully document in the respective quality management system.

• Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.

• Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.

• Creates high quality, compliant regulatory CMC documents within defined timelines as per Takeda's PDT BU objectives.

• Participates in discussions and negotiations with regulatory authorities, agents, business partners, proactively and as required.

• Assists in the conduct of regulatory agency inspections and compliance audits

Minimum Requirements/Qualifications:

• Bachelor’s degree in a scientific discipline (advanced degree preferred)

• 5+ years of biotechnology/pharmaceutical industry experience

• 3+ years of regulatory CMC experience (biologics or plasma preferred)

• Demonstrated ability to collaborate within teams and with key cross functional areas

• Demonstrated experience in authoring and managing components of regulatory submissions

• Good knowledge of global regulatory CMC requirements and experience with interactions/negotiations with global health authorities

• Strong oral and written communication and negotiation skills

• Highest level of compliance integrity and business adaptability

• The role requires an extensive experience in global pharmaceutical/biotechnological drug development and proven knowledge of the global regulatory CMC environment.

• Demonstrated experience in authoring and managing components of regulatory submissions

• Good knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with FDA. Support regional and local regulatory affairs teams for interactions with regional or local health authorities (e.g., EMA, PEI, AGES, PMDA, Health Canada, etc.).

• Demonstrated ability to develop and implement global CMC regulatory strategies, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.

• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve development and commercial goals.

• Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, drug development and/or expedited regulatory pathways.

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.

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:

USA - MA - Cambridge

U.S. Base Salary Range:

$133,000.00 - $209,000.00

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

USA - MA - Cambridge

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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