Regulatory affairs Jobs in Boston, MA

Job Description

Job Description

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 cross-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 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.

This is a ‘hands on’ position including, as needed :

Education & Experience

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 is :

$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 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 through the link below. 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.

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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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.