Title: Associate Director, Global RA Labeling Lead
Location: Cambridge, MA 02142 Hybrid – 2 days onsite per week
Duration: 6+ Months (Possible FT Conversion
Client: Takeda
Job Summary
Our client is seeking an Associate Director, Global RA Labeling Lead to join the Plasma-Derived Therapies (PDT) R&D organization. This role is part of the Global Labeling function and will provide regulatory expertise, strategic guidance, and leadership for global product labeling activities.
The primary focus of this position is biologics, with experience in plasma-derived products considered a plus. The successful candidate will lead global labeling strategy and development for Company Core Data Sheets (CCDS), U.S. Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC).
Key Responsibilities
Lead global regulatory labeling strategy for development and lifecycle management of CCDS, USPI, and EU labeling.
Develop Target Label Profiles (TLPs) and establish strategic labeling plans for new and marketed products.
Lead cross-functional Label Working Groups and drive alignment among Clinical, Pharmacovigilance, Legal, Scientific, Commercial, Regulatory, and other stakeholders.
Develop labeling recommendations and present proposals to the Global Labeling Oversight Committee for review and endorsement.
Interpret scientific, clinical, medical, and regulatory information to develop effective labeling strategies.
Provide regulatory guidance on U.S., EU, and international labeling requirements.
Develop and maintain labeling for pharmaceutical products and combination products/drug-device products.
Lead CCDS, U.S., and EU labeling teams through development, review, approval, and lifecycle management activities.
Use regulatory precedent, Health Authority feedback, and applicable guidance to develop innovative labeling strategies.
Prepare backup strategies to support Health Authority labeling negotiations.
Project manage labeling activities to ensure compliance with internal and Health Authority timelines.
Coordinate review and approval of labeling through cross-functional teams and governance committees.
Ensure submission-ready labeling components are prepared accurately and on time.
Maintain compliant version control and labeling documentation within electronic document management and tracking systems.
Ensure quality control of CCDS and other labeling documents.
Track labeling decisions, history, and compliance activities through end-to-end labeling systems.
Support and deliver training related to regulatory labeling processes and requirements.
Partner with Regulatory Intelligence and regional affiliates to assess regulatory changes and their impact on products.
Required Qualifications:
7–10+ years of experience in the biopharmaceutical industry, including experience in regulatory strategy, labeling, medical affairs, safety, advertising/promotion, or related areas.
5–7+ years of direct experience in global, U.S., or EU regulatory labeling preferred.
Strong experience with biologics; plasma-derived therapy experience is a plus.
Bachelor's or Master's degree required; advanced scientific or health sciences degree preferred.
Detailed understanding of pharmaceutical drug development and global regulatory requirements.
Strong knowledge of U.S. and EU labeling regulations and guidance.
Demonstrated expertise in development and maintenance of:
Company Core Data Sheet (CCDS)
U.S. Prescribing Information (USPI)
EU Summary of Product Characteristics (SmPC)
Experience with Target Label Profiles (TLPs) and global labeling strategy.
Knowledge of SPL format, including requirements for legacy and PLR labels.
Experience with Electronic Document Management Systems (EDMS) and end-to-end labeling tracking systems.
Combination product/drug-device labeling experience preferred.
Advertising and promotion experience is a plus.
Previous leadership or people-management experience preferred.
Preferred Skills:
Strong cross-functional leadership and stakeholder management skills.
Ability to influence senior stakeholders without direct authority.
Excellent verbal and written communication skills.
Strong strategic thinking, problem-solving, and decision-making abilities.
Ability to work effectively in a global, highly matrixed organization.
Ability to manage multiple priorities, timelines, and complex projects.
Strong understanding of global drug development and regulatory requirements.
Ability to lead diverse cross-functional teams and build consensus.
Work Schedule:
Hybrid – onsite 2 days per week: Tuesday and Thursday
Occasional early-morning meetings, including meetings around 7:00 AM, may be required but are infrequent.
Team Structure:
The Global Labeling Strategy team currently consists of four Labeling Strategists and is supported by Labeling Operations Leads and the broader Global Regulatory Affairs organization.
Ideal Candidate:
The ideal candidate is a senior regulatory labeling professional with strong biologics labeling experience, hands-on expertise with CCDS, USPI, and EU SmPC, and the ability to lead cross-functional labeling strategy. The candidate should be comfortable developing TLPs, driving Label Working Groups, influencing senior stakeholders, and presenting labeling recommendations to governance committees.
Benefits:
We offer a competitive compensation package that includes:
• [Pay Rate]: $125 - $130 per Hour
o Note: Pay rate will be commensurate with experience.
• Medical for full time employees
• Dental, and Vision Insurance
• Life Insurance, Short-Term Disability, Long-Term Disability, etc.