Associate Director, Global Regulatory Labeling Strategy

Takeda Pharmaceutical Co.; Agawam (MA); Hybrid; USD 154.000 - 243.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. seeks an Associate Director, Global Regulatory Labeling Strategy, to develop and implement labeling content for products across development stages.

You will lead cross-functional labeling teams and collaborate with global stakeholders to ensure scientifically accurate, compliant, and strategically aligned labeling. You will oversee TLPs, CCDSs, USPIs, and EU SmPCs, while coordinating with US/EU labeling operations and Health Authority interactions.

Qualifikationen

• Bachelor’s degree in a scientific discipline is required.
• An MSc, PhD, or PharmD is preferred.
• Experience creating or updating CCDSs, USPIs, and EU SmPCs.

Aufgaben

• Independently lead cross-functional labeling teams and align global labeling strategy.
• Coordinate labeling approval through GLOC with labeling/product leads.
• Prepare and align GLOC chairs and members for labeling reviews.
• Author and manage TLPs, CCDSs, USPIs, and EU SmPCs for assigned products.
• Develop labeling implementation plans incorporating new data and Health Authority feedback.
• Coordinate global labeling sub-functions to support end-to-end label development and submissions.
• Lead or support labeling negotiations with Health Authorities alongside Global Regulatory Lead.
• Interpret laws and guidance to ensure compliant labeling content and processes.

Kenntnisse

Cross-functional leadership

Project management

Regulatory interpretation

Negotiation

Communication skills

Attention to detail

Global labeling strategy

Ausbildung

Bachelor’s degree in a scientific discipline

Advanced scientific degree preferred (MSc/PhD/PharmD)

Jobbeschreibung

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 our R&D efforts on key therapeutic areas and targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

As the Associate Director, Global Regulatory Labeling Strategy, you will be responsible for developing and implementing labeling strategies and content for multiple products across various stages of drug development. Your portfolio may include a highly complex product and the creation or revision of Target Labeling Profiles (TLPs), Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), and European Union Summaries of Product Characteristics (EU SmPCs).

You will lead cross-functional labeling teams, collaborate with global stakeholders, and help ensure that Takeda’s product labeling is scientifically accurate, strategically aligned, competitive, and compliant with global regulatory requirements.

How You Will Contribute

• Independently lead cross-functional labeling teams, driving collaboration and alignment on global labeling strategy and content.
• Coordinate the labeling approval process through the Global Labeling Oversight Committee (GLOC), in partnership with the appropriate labeling and product leads.
• Prepare and align GLOC chairs, members, and their respective functions for labeling reviews and decisions.
• Author and manage new and revised TLPs, CCDSs, USPIs, EU SmPCs, and other labeling documents for assigned products.
• Develop and execute labeling implementation plans that incorporate new scientific, clinical, and safety data, as well as Health Authority feedback.
• Coordinate global labeling sub-functions to support timely end-to-end label development, Health Authority submissions, and labeling negotiations.
• Lead or support labeling negotiations with Health Authorities in collaboration with the Global Regulatory Lead.
• Interpret applicable laws, regulations, and guidance to ensure Takeda’s labeling content and processes comply with regulatory requirements.
• Manage the alignment of local labeling with the CCDS, including the assessment of local exceptions and alignment deferrals.
• Support local affiliates in responding to Health Authority requests and addressing local labeling requirements.
• Identify and elevate labeling risks and issues to Global Labeling leadership and the Global Regulatory Lead, while recommending appropriate mitigation strategies.
• Build effective partnerships across Clinical, Safety, Medical Affairs, Commercial, Regulatory, and other functions to support labeling strategy and content.
• Conduct precedent research and analyze competitor labeling, Health Authority requests, regulatory guidance, and emerging labeling trends.
• Develop labeling strategies and language that align with the overall product strategy and support competitive and compliant product labeling.
• Represent Global Labeling on Global Regulatory Teams and in departmental or cross-functional initiatives.
• Partner with US Labeling Operations, EU Labeling Operations, Labeling Devices, and Labeling Compliance to ensure objectives and timelines are met.
• Support US, EU, and global Health Authority inspections by responding to labeling-related information requests.
• Oversee labeling activities performed by external vendors, ensuring timely delivery, seamless coordination, and adherence to quality standards.
• Contribute to the continuous improvement of labeling processes by identifying and implementing opportunities to improve agility, efficiency, and accuracy.

Minimum Requirements and Qualifications

• Bachelor’s degree in a scientific discipline required. An advanced scientific degree, such as an MSc, PhD, or PharmD, is preferred.
• Eight or more years of pharmaceutical industry experience, including: Six years of labeling experience; or Five or more years of regulatory or related experience.
• Demonstrated experience creating, revising, or updating global product labeling, including CCDSs, USPIs, and EU SmPCs.
• Experience developing Target Labeling Profiles with limited supervision and guidance.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.
• Experience interpreting scientific, clinical, safety, and regulatory information for use in product labeling.
• Understanding of global regulatory requirements and regional labeling considerations.
• Knowledge of scientific principles and regulatory and quality systems relevant to drug development.
• Understanding of Health Authority audit and inspection processes.
• Strong project management skills, with the ability to independently manage priorities, timelines, and deliverables.
• Demonstrated ability to analyze complex regulatory issues, assess risk, and develop practical mitigation strategies.
• Excellent written, verbal, and presentation skills, with the ability to communicate complex regulatory information clearly and concisely.
• Demonstrated ability to lead multidisciplinary, cross-functional teams and build alignment among stakeholders with varied perspectives.
• Strong negotiation, stakeholder management, and conflict-resolution skills.
• Ability to work effectively in a global, matrixed environment and adapt to changing priorities.
• Strong attention to detail and a commitment to delivering accurate, complete, and high-quality labeling materials.
• Ability to promote an inclusive culture that encourages open dialogue, feedback, and diverse perspectives.

More About Us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are 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 and collaborative workplace where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This language follows the structure used in Takeda’s recent regulatory job-posting materials.

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$154,400.00 - $242,550.00

The 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.

For information about our benefits, please click here.

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt 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.

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