Crescent Biopharma , Inc.
Associate Director, Regulatory Operations
Crescent Biopharma , Inc., 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 The Associate Director, Regulatory Operations, will oversee the planning, management, and execution of regulatory submissions, ensuring high-quality dossiers that meet global regulatory standards. We are seeking someone experienced with the Veeva platform and its integration with other systems. Acting as a strategic partner and conduit between cross-functional teams, this individual will streamline submission and publishing processes and drive continuous improvement in tools, templates, and SOPs. With a focus on collaboration and excellence, this role is pivotal in ensuring timely, accurate submissions that align with organizational objectives and regulatory requirements.
Responsibilities
Establish and execute Regulatory Operations strategies aligned with company goals.
Serve as the primary Regulatory Operations Lead, collaborating with Regulatory Strategy to develop and manage submission timelines and processes.
Establish, train, and implement submission processes with internal teams and external partners.
Develop, review, and approve Regulatory Operations SOPs and governing documents.
Track submission timelines and ensure clear communication across global programs.
Oversee global submission preparation, timelines, distribution, and archiving, ensuring compliance with regulatory standards.
Manage and support Veeva platforms, and its integration into other systems as needed.
Serve as Submissions Manager for projects across the USA, EU, and other regions, collaborating on strategy and content planning.
Perform QC on all major regulatory submissions before filing with the respective Regulatory Authority.
Lead cross-functional meetings on submission planning for clinical, non-clinical, and CMC programs.
Drive continuous improvement on all Regulatory submission planning and execution related tools and templates.
Coordinate with medical writers and SMEs on regulatory submission documents (e.g., RTQs).
Train staff and serve as SME on regulatory systems, processes, and requirements.
Liaise with global regulatory CRO teams to ensure complete CTA packages and submissions.
Identify and troubleshoot regulatory gaps, conflicts, or process delays.
Manage document collection and respond to CRO requests related to submissions.
Oversee vendors handling submission publishing activities.
Education & Experience
Bachelor’s degree in a scientific discipline.
A minimum of 8 years of experience in Regulatory Operations, submissions management, or related roles involving regulatory interpretation and eCTD submission compilation.
Strong experience with USA, EU, and ROW submissions across multiple submission types.
Expertise in global eCTD standards and submission formats, with proficiency in publishing platforms (e.g., DocuBridge) and document management systems (e.g., Veeva).
High familiarity with FDA CFR, regulatory guidance interpretation, and tracking regulatory changes impacting submissions.
Strong organizational skills with the ability to manage multiple large-scale projects simultaneously.
Ability to work in a fast-paced, dynamic environment, handling aggressive timelines while maintaining composure under pressure.
Strong analytical skills with a high level of integrity in managing proprietary and confidential information.
Must be comfortable in a small company environment. Able to be 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 is:
$174,000 to $192,000 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.
E-Verify: Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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 The Associate Director, Regulatory Operations, will oversee the planning, management, and execution of regulatory submissions, ensuring high-quality dossiers that meet global regulatory standards. We are seeking someone experienced with the Veeva platform and its integration with other systems. Acting as a strategic partner and conduit between cross-functional teams, this individual will streamline submission and publishing processes and drive continuous improvement in tools, templates, and SOPs. With a focus on collaboration and excellence, this role is pivotal in ensuring timely, accurate submissions that align with organizational objectives and regulatory requirements.
Responsibilities
Establish and execute Regulatory Operations strategies aligned with company goals.
Serve as the primary Regulatory Operations Lead, collaborating with Regulatory Strategy to develop and manage submission timelines and processes.
Establish, train, and implement submission processes with internal teams and external partners.
Develop, review, and approve Regulatory Operations SOPs and governing documents.
Track submission timelines and ensure clear communication across global programs.
Oversee global submission preparation, timelines, distribution, and archiving, ensuring compliance with regulatory standards.
Manage and support Veeva platforms, and its integration into other systems as needed.
Serve as Submissions Manager for projects across the USA, EU, and other regions, collaborating on strategy and content planning.
Perform QC on all major regulatory submissions before filing with the respective Regulatory Authority.
Lead cross-functional meetings on submission planning for clinical, non-clinical, and CMC programs.
Drive continuous improvement on all Regulatory submission planning and execution related tools and templates.
Coordinate with medical writers and SMEs on regulatory submission documents (e.g., RTQs).
Train staff and serve as SME on regulatory systems, processes, and requirements.
Liaise with global regulatory CRO teams to ensure complete CTA packages and submissions.
Identify and troubleshoot regulatory gaps, conflicts, or process delays.
Manage document collection and respond to CRO requests related to submissions.
Oversee vendors handling submission publishing activities.
Education & Experience
Bachelor’s degree in a scientific discipline.
A minimum of 8 years of experience in Regulatory Operations, submissions management, or related roles involving regulatory interpretation and eCTD submission compilation.
Strong experience with USA, EU, and ROW submissions across multiple submission types.
Expertise in global eCTD standards and submission formats, with proficiency in publishing platforms (e.g., DocuBridge) and document management systems (e.g., Veeva).
High familiarity with FDA CFR, regulatory guidance interpretation, and tracking regulatory changes impacting submissions.
Strong organizational skills with the ability to manage multiple large-scale projects simultaneously.
Ability to work in a fast-paced, dynamic environment, handling aggressive timelines while maintaining composure under pressure.
Strong analytical skills with a high level of integrity in managing proprietary and confidential information.
Must be comfortable in a small company environment. Able to be 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 is:
$174,000 to $192,000 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.
E-Verify: Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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