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Crescent Biopharma · 1 month ago

Associate Director, Regulatory Operations

Waltham, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$174K/yr - $192K/yr

8+ years exp

Crescent Biopharma is focused on advancing oncology therapies for cancer patients. The Associate Director, Regulatory Operations, will oversee regulatory submissions, ensuring compliance with global standards while collaborating with cross-functional teams to streamline submission processes.

BiotechnologyHealth CareMedical Device

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

Qualification

Regulatory OperationsECTD submissionVeeva platformUSAEUROW submissionsDocuBridgeFDA CFR knowledgeAnalytical skillsOrganizational skillsCollaborationCommunication

Required

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