Crescent Biopharma · 1 month ago
Director, Regulatory Affairs
Waltham, MA
Full-time
Onsite
Director/Executive
$223K/yr - $246K/yr
8+ years expCrescent Biopharma is focused on advancing innovative therapies for cancer patients through its clinical-stage pipeline. The Director of Regulatory Affairs will lead the development and implementation of global regulatory strategies for investigational products, ensuring compliance and successful submissions across multiple regions.
BiotechnologyHealth CareMedical Device
Responsibilities
Develop and implement innovative global regulatory strategies to maximize the likelihood of regulatory success across multiple regions (US, Asia, EU, Australia)
Represent Regulatory on Program Teams to lead global regulatory strategy for assigned programs across development stages
Provide strategic, operational and tactical regulatory insight on one or more complex global programs in clinical development with a focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients
Serve as the global regulatory lead (GRL) on cross-functional teams for assigned programs, providing strategic input and regulatory expertise
Author regulatory documents (e.g. INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/MAA, submissions as needed
Develop/author and execute global regulatory strategies for complex strategies
Lead regulatory interactions with Health Authorities, external partners, and vendors for assigned products/projects
Work closely and collaboratively with other functions in the preparation of high-quality, timely submissions to Regulatory Agencies
Review and proofreading of administrative forms, cover letters, general correspondence for appropriate formatting accuracy, and completeness
Authoring Health Authority responses alongside subject matter experts
Management of submission activities for initial INDs, BLAs, amendments, Clinical Trial Applications, meeting requests/briefing materials, and as appropriate, expedited program designation requests, orphan drug designation requests, and Pediatric Study Plans
Reviewing and proofreading the nonclinical and clinical content of submissions for regulatory acceptability, accuracy and completeness
Preparing, reviewing or proofreading regulatory documents to clinical CROs requested for global clinical trial applications
Maintain working knowledge of the regulations and processes that govern the content and maintenance of documents required by the Health Authorities and ICH, and keeps up to date with the regulatory and competitor landscape
Perform other duties as required, interfacing with other departments, CROs, and external vendors/consultants
Qualification
Required
Bachelor's degree in a scientific discipline required
8-10 years of relevant pharmaceutical/biotechnology industry experience including experience in Regulatory Affairs related development of pharmaceuticals; phase 1 through BLA and post-approval
Oncology experience required
Experience in reviewing, authoring, or managing components of regulatory submissions
Solid working knowledge of the drug development process and regulatory requirements
Knowledge of FDA, EU, China, and ROW a plus
Working knowledge of eCTD elements and structure, ICH standards and submission requirements
Good regulatory writing and communication skills
Ability to balance multiple tasks to meet priorities and timelines
Flexible and comfortable with ambiguity
Preferred
Advanced scientific degree (PharmD or PhD) preferred
Benefits
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.
Participate in the Company’s savings plan (401(k)).
Eligible to participate in the Company’s 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.
Company
Crescent Biopharma
Crescent Biopharma is a biotechnology firm focused on developing novel precision-engineered medicines.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$585MKey Investors
Fairmount Funds Management
2025-12-04Post Ipo Equity· $185M
2025-06-16Post Ipo Equity· $200M
2025-06-16IPO
Recent News
2026-01-06
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