Strategist, Global Regulatory Affairs CMC, PDT (Sr Manager)
Takeda Pharmaceutical Company Limited
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RemoteAs a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda’s Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining therapies.
With an 80-year legacy of developing treatments for rare and complex chronic diseases, we thrive on innovation, offering a broad, differentiated portfolio of more than 20 plasma medicines with integrated care solutions to patients in more than 80 countries.
Powered by ~ 17,000 Takeda employees, our ~230 high-quality BioLife donation centers, a dedicated R&D team, and eight world-class plasma manufacturing facilities, we are unleashing data, digital and technology to transform our end-to-end operations and set new industry standards.
This enables us to innovatively and sustainably meet the growing and changing needs of patients, our people, and our planet, today and in the future.
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:
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 - CambridgeU.S. Base Salary Range:
$133,000.00 - $209,000.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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 - VirtualWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time#LI-Remote
Success profile
What makes a successful team member within PDT at Takeda?
- Bold thinker
- Systematic
- Innovative
- Collaborator
- Agile
- Tenacious
Our Los Angeles facility
Changing lives with plasma-derived therapies
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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This job is no longer accepting applications
See open jobs at Takeda Pharmaceutical Company Limited.See open jobs similar to "Strategist, Global Regulatory Affairs CMC, PDT (Sr Manager)" Greatness.bio.