Associate Director, Regulatory Affairs (Labeling) - FSP

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Summarized Purpose The Global Labeling & Lifecycle Document Specialist (GL&LDS) Team is responsible for managing global labeling activities and ensuring compliance with international regulatory standards. This role coordinates all aspects of labeling processes across foundational and dependent markets, including the preparation, submission, and maintenance of labeling documents. The position requires strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a matrixed environment. Acts as a labeling strategist within Global Regulatory Affairs (GRA), ensuring alignment of company position, labeling requirements, and commercial opportunities. Oversees end-to-end labeling development and implementation for foundational (US, EU, CH, DE, AU) and non-US/Central EU markets. Oversees regulatory review and approval of promotional and non-promotional materials to ensure global compliance. Manages global Clinical Trial Authorization (CTA) submissions and strategy, aligning labeling and regulatory documentation for clinical programs. Responsibilities Labeling Coordination & Management Coordinate readability testing, translations, and linguistic reviews for foundational markets (EU, CH, DE). Manage the preparation, review, and upload of approved labels to internal systems (Documentum, Weblabel, intranet) and external platforms (HA, ePIL). Dispatch CCDS, foundational labels, and multi-market manuscripts to dependent markets, stakeholders, and partners. Oversee and perform data entry for labeling systems (Trackwise, Veeva) and maintain labeling records. Maintain and update Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC). Lead Global Labeling Committee (GLC) assessments and manage exceptions between CCDS and regional labels. Governance & Compliance Support label content creation, including development of DLS and CCDS documentation. Prepare materials for Labeling Review Committee (LRC) and Global Labeling Committee (GLC), ensuring accurate record-keeping of decisions and minutes. Manage global labeling compliance activities, including quality control, FDA-508 compliance, and annual reporting requirements (US drug listing and NDC assignments). Coordinate impact assessments for technical and global labeling changes. Ensure compliance with country-specific regulatory requirements for labeling, submissions, and artwork approvals. Regulatory & Cross-Functional Support Prepare change control documentation and deviation reports for foundational and non-foundational markets. Manage Health Authority (HA) requests, RFIs, and label negotiations. Provide regulatory support for advertising, promotion, and medical education materials to ensure compliance with approved labeling and regional requirements. Collaborate with Medical Affairs, Legal, and Commercial teams to review and approve promotional and non-promotional materials. Manage Standard Operating Procedures (SOPs) and electronic review systems related to labeling and promotional review. Provide strategic input to therapeutic area teams and influence external labeling landscapes through competitive intelligence and regulatory insight. Act as key partner to GRA Regions, Regulatory CMC, and Supply Chain to ensure accurate and timely implementation of labeling decisions. Clinical Trial Regulatory Responsibilities Develop and oversee global Clinical Trial Authorization (CTA) submission strategy. Act as the regulatory interface between labeling, clinical operations, and global health authorities. Ensure compliance with EU Clinical Trial Regulation (CTR) and other regional regulatory requirements. Operational & Administrative Activities Maintain multi-market manuscripts and master artwork files. Coordinate administrative labeling updates (e.g., address or Windsor updates) for EU and other markets. Prepare annual strain update labeling (Northern and Southern Hemispheres). Participate in GRAST meetings and GL Leadership bi-weekly updates. Qualifications Minimum of 10 years of experience in the biotech or pharmaceutical industry, including 2+ years in labeling Demonstrated experience leading teams and initiatives in a matrixed organizational structure. In-depth knowledge of global labeling lifecycle management and regulatory requirements for US, EU, DE, CH, and AU markets. Proven ability to manage multiple complex projects under tight deadlines. Experience reviewing technical and scientific documents and influencing cross-functional teams. Familiarity with labeling for flu campaigns, pandemic products, and promotional material compliance. Experience with CTA submissions and coordination of global regulatory documentation preferred. Education and Experience Education: Bachelor’s degree (4-year degree) in Life Sciences, Chemistry, Engineering, or a related Pharmaceutical field. Preferred: Advanced degree (MSc, PhD, or PharmD). Experience: Minimum of 10+ years in the biotech/pharmaceutical industry with at least 2 years in regulatory labeling. 5+ years of management responsibility. Strong leadership skills. Technical Skills

Proficient with regulatory and document management systems, including:

RIMS: Veeva RIMS eDMS: Veeva, Apollo, Docubridge Change Management: Trackwise Other Tools: Microsoft Office Suite, SharePoint, Adobe Acrobat, TVT, Promomats, GLAMS

• Knowledge of Structured Product Labeling (SPL) preparation and submission.
• Understanding of FDA-508 compliance and digital labeling requirements.
• Experience with electronic promotional review and approval systems (e.g., Promomats) and CTA submission platforms.

Competencies

• Demonstrated ability to act as a labeling strategist and thought leader within Global Regulatory Affairs.
• Strong understanding of regulatory requirements relevant to global drug development, labeling, and post-marketing obligations.

Excellent analytical and problem-solving skills with the ability to assess risks and recommend effective solutions. Cross-functional collaboration and communication skills, with proven success working in culturally diverse global teams. Exceptional organizational skills to manage multiple priorities and ensure compliance with regulatory standards. Strategic and detail-oriented thinking, with the ability to influence and communicate complex concepts clearly. Fluent in English (verbal and written); additional languages are an asset.