Senior Regulatory CMC Lead - Biologics | Remote East Coast

Eastridge; Boston (MA); Hybrid; USD 200,000 - 234,000; Full time

Job summary

Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC activities supporting global BLA/MAA submissions, with a focus on Module 3, global regulatory strategy, and FDA/EMA interactions.

Local Boston candidates are preferred; remote East Coast candidates will also be considered. Occasional travel to Boston and Paris, France is required.

Qualifications

• 10+ years Regulatory Affairs CMC experience in biotech/pharma.
• Proven experience leading Module 3 for biologic BLA/MAA submissions.
• Strong biologics 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 experience

Module 3 experience

Biologics experience

ADC experience

Global regulatory strategy

FDA/EMA/ICH knowledge

Cross-functional collaboration

EST hours availability

Travel flexibility

Stakeholder management

Job description

Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC activities supporting global BLA/MAA submissions, with a focus on Module 3, global regulatory strategy, and FDA/EMA interactions.

Local Boston candidates are preferred; remote East Coast candidates will also be considered. Occasional travel to Boston and Paris, France is required.