Associate Director, CMC Regulatory

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

Not verified checked Jun 13, 2026

Salary

$145K-$207K not verified - source not recorded; timestamp not recorded

401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

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Schedule

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Weekend work

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Application

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Assessment

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Deadline

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Where they hire

State eligibility is not yet verified.

About this role

Associate Director, CMC Regulatory Cambridge, MA The Opportunity: As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: - You will serve as CMC-regulatory lead for assigned projects. - Develop and execute CMC global submission plans and timelines in accordance with project goals - You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs. - You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs. - You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management, as applicable. - You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership. - You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects. Competencies: - Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions. - Proven ability to lead and manage regulatory CMC projects with minimal supervision - In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH). - Positive attitude, energetic and proactive. - Strong technical writing and

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