Executive Director, Regulatory Affairs CMC

Crescent Biopharma; Waltham (MA); On-site; USD 290,000 - 323,000; Full time

Benefits offered by this job

100% employer-paid benefits package

Flexible PTO with two company shutdown

Long-term incentive program

Professional development resources

Job summary

Crescent Biopharma is seeking a senior Regulatory Affairs CMC leader to oversee global submissions and ensure compliance across the product lifecycle. You will lead IND/MAA programs, negotiate with FDA/EMA, and guide TechOps and Quality to readiness for clinical and commercial supply.

The role requires 12+ years in CMC regulatory affairs, strong negotiation skills, and experience with biologics/ADC platforms. Leadership and strategic thinking are essential in a fast-paced environment.

Qualifications

• BS/BA Degree in a scientific discipline; advanced degree (MS/PhD) preferred.
• 12+ years in Regulatory Affairs CMC within Pharma/Biotech.
• Strong negotiation with health authorities (FDA/EMA) and submissions.
• Experience leading INDs and Marketing Applications (MAA).
• Experience with antibody-drug conjugates and biologics.
• Strong analytical, strategic thinking and problem-solving.
• Excellent communication and leadership; able to influence across levels.

Responsibilities

• Lead and/or oversee global regulatory CMC submissions through product lifecycle.
• Proactively identify regulatory risks, opportunities, and mitigation strategies with management.
• Provide strategic regulatory guidance to TechOps and Quality for global compliance.
• Serve as primary interface with global regulatory agencies for CMC negotiations & information requests.
• Provide regulatory input on product-compliance activities including change controls & investigations.
• Manage junior team members and contractors to support development activities.

Skills

Regulatory CMC

IND/CTA/MAA submissions

FDA/EMA negotiations

Leadership

Strategic thinking

Biologics/ADC experience

Communication

Team management

Education

BS/BA in scientific discipline

MS/PhD preferred

Job description

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.

• 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

• 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
• Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
• Competitive compensation, including base salary, performance bonus, and equity
• 100% employer-paid benefits package
• Flexible PTO; also, two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities

The 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.

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

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.