Associate Director, Regulatory Operations

Crescent Biopharma , Inc. • Waltham, MA

32d

About The Position

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.

Requirements

• Bachelor’s degree in a scientific discipline.
• A minimum of 5 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level