Sr. Manager, Regulatory Affairs - CMC

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 early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role:

The Senior Manager, Regulatory Affairs-CMC will play a key role in supporting regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.   This role is accountable for the planning and technical execution of the CMC regulatory strategy and for representing Regulatory Affairs-CMC in cross-functional teams and with external partners. 

 Responsibilities:

• Provide strategic regulatory CMC leadership, consultation, and guidance to project teams
• Develop and execute on CMC submission plans and timelines in accordance with project goals
• Lead the preparation and review of CMC sections of regulatory dossiers for global health authority submissions in collaboration with project teams
• Manage health authority meetings including the preparation of meeting requests and briefing documents
• Triage and coordinate responses to CMC questions/requests for information from regulatory authorities
• Manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations
• Lead projects with cross-functional teams and act as the primary regulatory CMC contact
• Contribute to initiatives to improve processes and procedures within the Regulatory Affairs department
• Keep abreast of regulatory guidance and technical/scientific developments relevant to projects

 

Competencies Include:

• Possess excellent problem-solving abilities
• Experience with review and/or providing content for CMC/Quality regulatory submissions, including IMPD and IND development/maintenance. Experience with NDAs is a plus.
• Excellent organizational and communication skills, both written and verbal
• Positive attitude, energetic and proactive
• Strong attention to detail and the ability to multi-task in a fast-paced environment
• Strong interpersonal skills and the ability to effectively work individually, within a cross-functional team, as well as with external partners and vendors
• Demonstrates leadership skills as a regulatory CMC expert on project teams

  Qualifications:

• Bachelor of Science degree and/or in a field related to pharmaceutical sciences
• 5-8 years of experience in Regulatory-CMC or within a CMC function (e.g. Analytical, Formulations, Process Chemistry, QA, QC) in the biotech/pharmaceutical industry
• Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs
• Knowledge of current regulatory guidelines (FDA/ICH) pertaining to drug development, with particular emphasis on CMC/Quality

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

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