Crescent Biopharma
Director, Regulatory Affairs
Crescent Biopharma, Waltham, Massachusetts, United States, 02254
About Us
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s 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 either as single agents or 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.
Position Overview Our Director, Regulatory Affairs, will support the development and implementation of global regulatory activities for investigational products within the company’s pipeline. The successful candidate will have hands‑on expertise in developing robust regulatory strategies for novel oncology compounds. Knowledge of global regulations is necessary to provide regulatory support to ongoing global clinical trials and to review global submissions to these trials. This individual will operate in a high visibility role actively contributing to the development and implementation of regulatory strategy including identifying and assessing regulatory risks and interfacing with the authorities. They will collaborate with‑functional teams to provide regulatory guidance, drive health authority interactions, and manage regulatory submissions. As a key liaison between internal teams and external partners, you will help communicate regulatory plans and updates, ensuring alignment with company goals. This individual must be comfortable in a small company environment and bring hands‑on experience.
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 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.
Hands‑On Position Including, as Needed
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.
Education & Experience
Bachelor’s degree in a scientific discipline required; Advanced scientific degree (PharmD or PhD) preferred.
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.
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.
Two, one‑week company‑wide shutdowns each year.
A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
The Anticipated Base Pay Range For This Position Is3> $223,000 to $246,000 USD
Additional Description For Pay Transparency 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 shutdowns; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found at https://www.crescentbiopharma.com/careers/#benefits
E-Verify Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Equal Opportunity Employer 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.
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Position Overview Our Director, Regulatory Affairs, will support the development and implementation of global regulatory activities for investigational products within the company’s pipeline. The successful candidate will have hands‑on expertise in developing robust regulatory strategies for novel oncology compounds. Knowledge of global regulations is necessary to provide regulatory support to ongoing global clinical trials and to review global submissions to these trials. This individual will operate in a high visibility role actively contributing to the development and implementation of regulatory strategy including identifying and assessing regulatory risks and interfacing with the authorities. They will collaborate with‑functional teams to provide regulatory guidance, drive health authority interactions, and manage regulatory submissions. As a key liaison between internal teams and external partners, you will help communicate regulatory plans and updates, ensuring alignment with company goals. This individual must be comfortable in a small company environment and bring hands‑on experience.
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 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.
Hands‑On Position Including, as Needed
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.
Education & Experience
Bachelor’s degree in a scientific discipline required; Advanced scientific degree (PharmD or PhD) preferred.
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.
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.
Two, one‑week company‑wide shutdowns each year.
A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
The Anticipated Base Pay Range For This Position Is3> $223,000 to $246,000 USD
Additional Description For Pay Transparency 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 shutdowns; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found at https://www.crescentbiopharma.com/careers/#benefits
E-Verify Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Equal Opportunity Employer 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.
#J-18808-Ljbffr