Director Regulatory affairs global Labeling

They are responsible for the development, implementation, and management of labeling content and strategy for multiple pharmaceutical products across various stages of drug development. This role ensures compliance with regulatory requirements while optimizing labeling strategies to align with business objectives.

Key Responsibilities:

• Lead cross-functional labeling teams, driving collaboration and strategic alignment.
• Develop and update key labeling documents (TLP, CCDS, USPI, EU SmPC).
• Manage the labeling approval process with senior management and regulatory teams.
• Provide strategic guidance on labeling trends, competitor analysis, and regulatory requirements.
• Oversee global labeling implementation plans to ensure compliance and minimize risks.
• Act as the primary liaison with health authorities, leading label negotiations.
• Support local affiliates in aligning regional labeling with global standards.
• Drive continuous improvement in labeling processes and vendor management.

Qualifications & Skills:

• Bachelor's degree required; advanced degree (MSc, PhD, or PharmD) preferred.
• 10 years of pharmaceutical industry experience, including 6 years in regulatory labeling.
• Expertise in US and EU labeling regulations and submission processes.
• Strong leadership, project management, and cross-functional collaboration skills.
• Excellent communication, problem-solving, and negotiation abilities.

Job Type: Contract

Pay: $80.00 - $95.00 per hour

Schedule:

• 8 hour shift

Experience:

• Labeling: 8 years (Required)
• Regulatory affairs: 8 years (Required)
• Pharmaceutical/Biotechnology industry: 10 years (Required)

Ability to Commute:

• Cambridge, MA 02142 (Required)

Work Location: In person

Salary : $80 - $95