Director, Global Regulatory Labeling Strategy

Core4ce Careers; Cambridge (MA); Hybrid; USD 209,000 - 259,000; Full time

Job summary

Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements.

You will influence senior stakeholders, oversee USPI/CCDS labeling, manage SPL submissions, and drive lifecycle labeling from development through post-marketing. This role supports hybrid in-office engagement amid relocation plans to Waltham.

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• 10+ years of pharmaceutical/biotech experience with regulatory labeling for prescription products.
• Experience leading labeling strategy across development and/or marketed products.
• Global labeling experience (FDA, EMA, and ICH regions).

Responsibilities

• Define and lead global labeling strategy across development and marketed products.
• Serve as the primary regulatory authority on labeling, advising senior leadership on risks and opportunities.
• Drive labeling as a core component of overall regulatory and product strategy, including differentiation and lifecycle optimization.
• Lead labeling teams across Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC.
• Oversee development, negotiation, and maintenance of USPI, CCDS, and local labeling.
• Ensure alignment and governance for regulatory labeling across markets.

Skills

Regulatory labeling leadership

Cross-functional leadership

Global labeling experience

Education

Bachelor’s degree in a scientific or related discipline

Advanced degree (MS, PharmD, PhD, JD)

Job description

Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements.

You will influence senior stakeholders, oversee USPI/CCDS labeling, manage SPL submissions, and drive lifecycle labeling from development through post-marketing. This role supports hybrid in-office engagement amid relocation plans to Waltham.