Associate Director, Global Regulatory Labeling Strategy

Takeda; Boston (MA); Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Global Regulatory Labeling Strategy in Massachusetts (Virtual) to lead global labeling strategy and content for multiple products. You will coordinate GLOC processes, author CCDSs/USPI/EU SmPCs, and align local labeling with CCDS while managing risks and negotiations with Health Authorities.

You will guide cross-functional teams across Clinical, Safety, Medical Affairs, and Regulatory to implement labeling plans that reflect new data, safety signals, and

Qualifications

• Bachelor’s degree in a scientific discipline required.
• Eight or more years in pharma with labeling experience; or five+ years in regulatory roles.
• Experience creating or updating CCDSs, USPIs, and EU SmPCs.
• Experience developing Target Labeling Profiles (TLPs).
• Strong knowledge of US and EU labeling requirements and guidelines.
• Ability to interpret scientific and regulatory data for labeling.

Responsibilities

• Lead cross-functional labeling teams, guiding global labeling strategy and content.
• Coordinate labeling approvals through GLOC with labeling and product leads.
• Prepare and align GLOC chairs and members for labeling reviews.
• Author and manage TLPs, CCDSs, USPIs, EU SmPCs and other labeling documents.
• Develop labeling implementation plans incorporating new data and authority feedback.
• Support end-to-end label development, submissions, and negotiations.
• Lead or support labeling negotiations with Health Authorities.
• Ensure compliance with regulatory requirements across regions.
• Align local labeling with CCDS and manage local exceptions.
• Identify labeling risks and propose mitigation strategies.

Skills

Global labeling strategy

Cross-functional leadership

US/EU labeling expertise

Project management

Regulatory writing

Stakeholder management

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MSc/PhD/PharmD) preferred

Job description

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).

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.

Benefits

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:

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.