Associate Director, Global Regulatory Affairs - Labeling Lead

About the role

If you thrive on steering high-stakes global labeling strategy—from CCDS creation to FDA and EMA negotiations—this is your platform. Take ownership of labeling for life-changing plasma therapies and drug-device combination products, leading cross-functional teams and cutting through complexity to shape product messaging worldwide. Location: Cambridge, Massachusetts. Contract position.

Responsibilities

• Drive global regulatory labeling strategy and lifecycle management for CCDS, US, and EU labels across plasma-derived therapies.
• Lead cross-functional labeling teams and align stakeholders across Clinical, Safety, Legal, and Commercial functions.
• Interpret scientific and clinical data to develop prescribing information while ensuring compliance with FDA and EMA regulations.
• Manage end-to-end labeling updates, submission-ready components, tracking systems, and document version control.
• Provide strategic guidance on drug-device combination product labeling and health authority submission plans.

Qualifications

Required:

• Bachelor's or Master's degree.
• Minimum of 7-10 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.) with 5-7 years of direct experience in a global, US, or EU labeling role.
• Detailed understanding of pharmaceutical drug and device development and global regulations pertaining to labeling, specifically EU and US labeling requirements and guidance.
• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
• Understanding of SPL format, requirements and guidance for legacy and PLR labels.
• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

Preferred:

• Advanced scientific or health sciences degree or equivalent relevant experience.
• Experience in plasma-derived therapies and biologics.
• Previous leadership experience and management of direct reports.
• Combination product/drug-device labeling knowledge.
• Advertising and promotion knowledge.

Skills

• Marketing Authorization Application (MAA)
• FDA Submissions

Benefits

• Medical insurance
• Prescription coverage
• Dental insurance
• Vision insurance
• AD&D insurance
• Life insurance
• Short-term disability
• 401K plan

Pay

$100 – $131 per hour

Schedule

9 to 5