Executive Director, Regulatory Affairs CMC

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.

\nResponsibilities

• 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

Education & Experience

• 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

What We Offer

• 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

Salary Range\n

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.

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