Executive Director, Regulatory Affairs CMC

Job overview

The Executive Director, Regulatory Affairs CMC role is onsite in Waltham, MA. The salary range is $290,000–$323,000 per year. Crescent Biopharma is developing oncology therapies, including a PD-1 x VEGF bispecific antibody and antibody-drug conjugates. The role leads global regulatory CMC strategy and submissions across product lifecycles, supporting compliant clinical and commercial supply. It serves as the primary interface with regulatory agencies on CMC matters and guides cross-functional teams through regulatory risks, negotiations, and product-compliance activities.

What you'll do

• Lead or oversee global regulatory CMC submissions through product lifecycles
• identify regulatory risks and mitigation strategies
• advise TechOps and Quality on global compliance and supply readiness
• serve as primary interface with regulatory agencies for CMC negotiations, meetings, and information requests
• support change controls, deviations, and investigations
• manage junior team members and contractors.

What we're looking for

Skills & competencies

executive director

regulatory affairs

cmc

biopharma

oncology

global submissions

biologics

waltham ma

crescent biopharma

$290k–$323k/year

12+ years experience

Work arrangement

• Weekend coverage required

Benefits & perks

• Performance bonus and equity
• employer-paid benefits
• medical, dental, vision, and life insurance
• short- and long-term disability
• 401(k)
• unlimited PTO
• 10 sick days
• holidays and company shutdowns
• 16 weeks of parental leave
• professional development.

About the employer

Crescent Biopharma is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.