Regulatory Labeling Associate Director

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Implement strategic labeling for one or more products at the global label level or across various ROW countries/regions.

• Ensure adherence to labeling governance requirements and associated business processes.

• Lead label working groups.

• Represent labeling at high-level governance meetings.

• Develop and maintain global product labeling, which includes company core datasheets, major-market labels, ROW market-specific labels, packaging components, and target label profiles.

• Contribute to the overall labeling strategy.

• Provide guidance to stakeholders on regulatory labeling requirements pertaining to quality, preclinical, and clinical data.

• Oversee interactions with health authorities regarding labeling across products or ROW markets.

• Manage responses to inquiries, negotiations, and inspections.

• May assume responsibility for specific business processes.

• May develop and manage a Target Label Profile (TLP) under guidance.

⛳️ Requirements

• Bachelor’s degree, ideally in a life sciences field.

• Typically, 8 years of experience in regulatory affairs related to global labeling or a similar discipline, or an equivalent combination of education and experience.

• Specialized knowledge of global labeling requirements.

• Understanding of the development and life-cycle management of Core Company Data Sheets (CCDS).

• Familiarity with global regulatory authorities, including FDA and EMA; may also include Health Canada and TGA.

• Advanced capability to develop, utilize, and implement regulatory global and/or regional labeling frameworks.

• Advanced skills in planning, prioritizing, leading, and executing regulatory labeling tasks, teamwork, and projects.

• Strong comprehension of labeling compliance and operational requirements.

• Ability to adopt and leverage emerging technologies, including AI-driven tools.

• Commitment to continuous learning and awareness of technology, AI, automation, competitive intelligence, and regulatory changes.

🏝️ Benefits

• Eligibility for annual bonuses.

• Annual equity awards.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Generous paid time off.

• Company-wide shutdown for one week in the summer.

• Company-wide shutdown for one week in the winter.

• Educational assistance programs.

• Student loan repayment assistance.

• Commuting subsidy.

• Matching contributions for charitable donations.

• 401(k) retirement plan.

• Option for remote work five days per week.

• Hybrid work arrangement available.

• On-site work option with ad hoc flexibility.