Senior Regulatory CMC Lead

About the role

Eastridge Workforce Solutions is seeking an experienced 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. Location: Boston, MA / Remote East Coast. Employment Type: Full-Time | Temporary, 6 months with potential for extension or conversion. FLSA Status: Non-Exempt. Local Boston candidates are preferred; remote East Coast candidates will also be considered. Occasional travel to Boston and Paris, France is required.

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.

Requirements

• 10+ years of Regulatory Affairs CMC experience in biotech/pharma.
• Proven experience leading Module 3 for a biologic BLA and/or MAA submission.
• 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.

Benefits

Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements. Use this link https://applicantcenterstorage.blob.core.windows.net/public-documents/EWSb1cb390e-729b-47eb-ab2f-b92adafbdd07-2024EplicaBenefitSummaryTempExternal.pdf to learn more about benefits available to Eastridge’s temporary employees. Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions’ Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based. However, from time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Pay

Hourly Pay Range: $145–$170/hr

Schedule

Shift: Monday–Friday, EST business hours. Schedule: 40 hours/week.