New · posted Oct 15
Crescent Biopharma · Biotechnology
Executive Director, Regulatory Affairs CMC
- Waltham, MA
- On-site
- Full-time
- Director
Open until filled
The role
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
What you need
Skills named in this posting
- Global regulatory CMC submissions (IND, CTA, BLA, MAA)
- Health authority negotiation (FDA, EMA)
- Leading IND and marketing applications
- Antibody drug conjugates and biologics
- Regulatory strategy and risk management
- Change control, deviations and investigations support
- Team and contractor management
- Leadership and cross-functional influence
What you'll do
- Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product lifecycle.
- Proactively identify regulatory risks, opportunities, and mitigation strategies in alignment with objectives, and communicate to management, as needed
- Provide strategic regulatory guidance to TechOps and Quality organizations to ensure global compliance and readiness for clinical and commercial supply
- Serve as the primary interface with global regulatory agencies for CMC-related negotiations, milestone meetings, and information requests.
- Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
- Manage junior team members and contractors to support development activities
Pay
$290,000 – $323,000 a year
Employer providedThe salary range for this position is $290,000 to $323,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Where you'll work
Waltham, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Waltham, MAEqual opportunity, accessibility and legal noticesCrescent Biopharma's statements, word for word
Additional Description for Pay Transparency
The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits
Please note:
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 46% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in Massachusetts20 roles publishing pay
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $290,000 | — | $323,000 |
| Massachusetts (middle half) | $199,625 | $222,500 | $244,125 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Crescent Biopharma's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Crescent Biopharma's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 8 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- GMP and compliance2
- Regulatory submissions2
- Lab testing and methods1
- Investigations and CAPA1
- Quality systems and risk1
- Global regulatory CMC submissions (IND, CTA, BLA, MAA)
- Health authority negotiation (FDA, EMA)
- Leading IND and marketing applications
- Antibody drug conjugates and biologics
- Regulatory strategy and risk management
- Change control, deviations and investigations support
- Team and contractor management
- Leadership and cross-functional influence
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Crescent Biopharma on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Director3 100%
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Executive Director, Regulatory Affairs CMC at Crescent Biopharma
Open until filled. $290K–$323K a year, employer provided.