Executive Director, Regulatory Affairs CMC

Crescent Biopharma•Waltham, MA

19h

About The Position

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.

Requirements

BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required
12 years’ experience in Regulatory Affairs CMC in Pharma/Biotech
Strong negotiation skills with health authorities (e.g. FDA, EMA) as well as submissions
Experience with leading IND and Marketing Applications
Experience with antibody drug conjugates and biologics
Strong analytical, strategic thinking, and problem-solving skills.
Excellent communication and leadership abilities; able to influence across all levels of the organization.
Ability to thrive in a fast-paced, ambiguous environment while managing competing priorities.
Commitment to fostering a diverse and inclusive workplace

Responsibilities

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

Benefits

Competitive compensation, including base salary, performance bonus, and equity
100% employer-paid benefits package
Flexible PTO
Two, one-week company-wide shutdowns each year
A commitment to your professional development, with access to resources, mentorship, and growth opportunities
medical, dental, vision, life insurance, short- and long-term disability
401(k)
long-term incentive program
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