Global Regulatory CMC Lead - Biologics (Remote/East Coast)

Eastridge Workforce Solutions; Boston (MA); Hybrid; USD 415,484,000 - 487,119,000; Full time

Job summary

Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead in the Boston area with EST hours and potential for remote East Coast work. The role involves strategic CMC leadership for a global biologics program, leading Module 3 and global regulatory strategy, and coordinating FDA/EMA interactions.

Occasional travel to Boston and Paris is required. Preferred candidates will have 10+ years in Regulatory Affairs CMC within biotech/pharma and strong cross-functional, international

Qualifications

• 10+ years of Regulatory Affairs CMC experience in biotech/pharma.
• Proven experience leading Module 3 for biologic BLA/MAA submissions.
• Strong biologics Regulatory CMC expertise; ADC experience preferred.
• Experience developing and executing global Regulatory CMC strategies.
• Strong knowledge of FDA, EMA, and ICH requirements.
• Experience working with cross-functional and international teams.
• Strong strategic thinking, communication, and stakeholder management skills.
• Ability to work EST hours and travel occasionally to Boston and Paris.

Responsibilities

• Lead global Regulatory CMC strategy for a biologic/ADC program.
• Lead CMC activities for global BLA and/or MAA submissions.
• Oversee preparation, review, and finalization of Module 3.
• Support FDA, EMA, and other global health authority interactions.
• Lead responses to regulatory questions and deficiencies.
• Partner across Regulatory, CMC, Quality, Manufacturing, and global project teams.
• Identify regulatory risks and develop mitigation strategies.

Skills

Regulatory CMC leadership

Global regulatory strategy

FDA/EMA/ICH knowledge

Cross-functional collaboration

Biologics regulatory CMC

Job description

Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead in the Boston area with EST hours and potential for remote East Coast work. The role involves strategic CMC leadership for a global biologics program, leading Module 3 and global regulatory strategy, and coordinating FDA/EMA interactions.

Occasional travel to Boston and Paris is required. Preferred candidates will have 10+ years in Regulatory Affairs CMC within biotech/pharma and strong cross-functional, international