Senior Regulatory CMC Lead

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

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Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading...

Eastridge Workforce Solutions is committed to connecting skilled professionals with meaningful career opportunities. We are seeking a Senior Regulatory CMC Lead to support our client’s global Regulatory Affairs team.

Created/Revised Date: September 23, 2026

Anticipated Closing Date: September 30, 2026

Job Title: Senior Regulatory CMC Lead

Location: Boston, MA / Remote East Coast

Shift: Monday-Friday, EST business hours

Hourly Pay Range: $145-$170/hr

Employment Type: Full-Time | Temporary, 6 months with potential for extension or conversion

FLSA Status: Non-Exempt

Schedule: 40 hours/week

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

Essential Duties and 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.

Disclaimer: The compensation and benefits information in this posting represents Eastridge’s good faith and reasonable estimate of what it might pay for this position. Eastridge reserves the right to modify this information at any time, subject to applicable law.

Equal Opportunity Employer: Eastridge Workforce Solutions is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity,and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity,genderexpression, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Eastridge Workforce Solutions also prohibits harassment or retaliation of applicants or employees based on any of these protected categories. It is our policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Background Checks: Certain clients require Eastridge Workforce Solutions to perform background checks. Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the California Fair Chance Act, the Los Angeles City Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance.

Massachusetts Candidates: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Privacy: Information collected and processed as part of your candidate profile, job application, resume, and/or any other information you choose to submit is subject to Eastridge’s Privacy Policy: https://www.eastridge.com/privacy-policy , as well as Eastridge’s Pre-Use Notice of Collection and Automated Decision-Making Technologies: https://www.eastridge.com/data-collection-notice . By applying for this position, you consent to being contacted by Eastridge Workforce Solutions and its agents or authorized service providers regarding employment opportunities, assignments, and the recruiting process. Communications may be by phone call, AI-assisted or AI-generated phone call (where permitted by law), automated text message (SMS), or email. The purposes for these communications may include, but are not limited to, confirming your interest in available opportunities, scheduling interviews, conducting initial screening conversations, and collecting information relevant to your application. Message frequency may vary. Standard message and data rates may apply depending on your mobile carrier. You may opt out of receiving text messages at any time by replying "STOP" to any SMS message. For additional information regarding our text messaging practices, please review our SMS Terms and Conditions at: https://www.eastridge.com/sms-terms-and-conditions . You may opt out of receiving e-mail by clicking the "Unsubscribe" button.