Senior Manager, Regulatory Affairs

Nuvalent, Inc.•Cambridge, MA

About The Position

Nuvalent is an early-stage company with deep expertise in chemistry, focused on creating selective medicines for patients with cancer. The Senior Manager, Regulatory Affairs role will integrate regulatory strategic development, submission management expertise, and hands-on execution to support the IND/CTA stage of development through NDA/MAA. This role will contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). The Senior Manager, Regulatory Affairs must stay current with evolving Health Authority requirements to facilitate regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA.

Requirements

6-8 years of experience in Regulatory Affairs or combination of education and direct experience.
Bachelor or advanced degree in a scientific field or equivalent work experience is required.
Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes.
Solid understanding of the e-CTD specifications for electronic submissions.
Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD and CDER requirements for the drug approval process.
Previous participation in preparing and/or leading regulatory submissions (IND, CTA, NDA, etc.).
Experience in interpretation of regulations, guidelines and precedents related to drug development in the US and EU.
Strong understanding of regulatory eCTD structure and clinical trial conduct and design
Proficiency with electronic submission publishing software and document management information systems (i.e., docuBridge, Veeva Vault RIM)
Ability to plan, prioritize and contribute to work and projects in a systematic and efficient manner with emphasis on streamlining processes

Nice To Haves

Master’s degree a plus.
Experience with preparing meeting packages is a plus.

Responsibilities

Participates as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved
As part of the regulatory clinical study team, you will support preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.)
Provide regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning)
Ensure collaboration with and coordination of cross-functional project teams for timely execution of regulatory submissions, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight
Support regulatory operations during the regulatory submissions handoff process, as the primary point of contact for external publishing vendors, ensuring submission packages are accurate, formatted correctly, and validated.
Maintain the regulatory information system and ensure proper archiving, searchability, and accessibility of regulatory content including correspondence with regulatory agencies
Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned
Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate
Ensure compliance with internal SOPs, regulations and applicable laws. Drafts and reviews Regulatory Affairs SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required