Senior Manager, Regulatory Affairs

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

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• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

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Salary

$160K-$185K From the posting source

401(k) match

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Role

Seniority

Senior From the posting source

Work mode

Remote From the posting source

In-office days

0 days From the posting source

Schedule

Shift type

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Weekend work

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Company

Equity

Offered Verified - SEC 10-K source

Application

Cover letter

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Assessment

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Deadline

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Where they hire

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About this role

Senior Manager, Regulatory Affairs Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Director, Global Regulatory Affairs, 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. The Senior Manager, Regulatory Affairs will contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). This role will manage the process for preparation, submission and internal review and approval of regulatory documents, including providing technical regulatory input for global documents to streamline development. The Senior Manager, Regulatory Affairs must be kept current, innovative, and compliant with the constant changing Health Authority requirements to facilitate regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA. 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

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