56 applicants

Company

Original Job Post

Nuvalent, Inc. · 2 days ago

Director, Regulatory Operations

Cambridge, MA

Full-time

Remote

Director

10+ years exp

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BiotechnologyLife Science

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Responsibilities

Provide regulatory operations expertise and leadership to cross functional teams supporting the pipeline.

Lead the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities. As needed, train colleagues and project teams.

Oversee and manage all Regulatory Operations submissions, systems related projects and submission compliance.

Oversee technical aspects for submissions (e.g., eCTD document formatting, eCTD application, and transmission to regulatory health authorities).

Perform quality assurance of submission documents and published output to ensure compliance with global eCTD requirements.

Manage all internal and external publishing staff.

Plan, schedule, and coordinate submissions.

Maintain regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions.

Oversee the maintenance and optimization of Veeva Vault RIM.

Ensure the accuracy, integrity, and security of regulatory data within the Veeva Vault system.

Provide training and support to team members on the use of Veeva Vault RIM.

Build submission binders and content plans for future regulatory submissions

Stay current with regulatory requirements and industry best practices.

Implement and maintain regulatory policies and procedures to ensure compliance.

Prepare and present regulatory reports, metrics, and dashboards.

Qualification

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Regulatory AffairsRegulatory OperationsIND/CTA FilingNDA/MAA FilingRegulatory Submission PublishingWord ProcessingElectronic Document Management SystemsRegulatory Publishing SoftwareDrug Development ProcessesECTD SubmissionsEnterprise Document Management SystemsVeeva RIMFDA GuidelinesEMA GuidelinesICH GuidelinesDrug Development RegulationsIND GuidelinesNDA/BLA Guidelines

Required

Bachelor’s Degree in relevant/scientific field or related experience.

10+ years of work experience in pharmaceutical/biotech regulatory affairs, with at least 8 years of Regulatory Operations experience

IND/CTA and NDA/MAA filing experience.

Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software

Understanding of drug development and business processes.

Knowledge and experience of eCTD submissions.

Knowledge and experience with enterprise document management systems (eDMS), specifically Veeva RIM.

Knowledge of FDA, EMA, and ICH guidelines.

Understanding of regulations and guidelines for drug development for IND and NDA/BLA.

Company

Nuvalent, Inc.

Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.

Founded in 2017

Cambridge, Massachusetts, USA

11-50 employees