Manager, Regulatory Advertising & Promotion Submissions Job at Nuvalent, Inc. in

Manager, Regulatory Advertising & Promotion Submissions

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.

Role

Reporting to the VP, US Regulatory Advertising & Promotional Labeling, the Manager, Regulatory Advertising & Promotion Submissions will utilize Veeva PromoMats to support the compliant preparation, review, and submission of branded promotional material to the Office of Prescription Drug Promotion (OPDP).

Responsibilities

• Serves as system subject matter expert and maintains knowledge of Veeva PromoMats functionality pertaining to compliance binder generation and related workflows.
• Leads the regulatory review process of compliance binders through PromoMats system.
• Attends regularly scheduled submission plan meetings and collaborates with Commercial Operations and Project Owners to formulate and adhere to planned submission schedules.
• Tracks status of pre‑submissions and close of FDA review periods for products subject to accelerated approval advertising and promotion requirements (21 CFR 314 Subpart H).
• Performs quality checks on all submission components within Veeva‑generated compliance binders.
• Assists in establishing naming conventions for Veeva submission compliance binders and Regulatory archive folders.
• Consults with colleagues within Regulatory Affairs and leads in the coordination, quality control, preparation and archiving of promotional material eCTD submissions.
• Maintains a thorough understanding of OPDP submission requirements.
• Generates submission reports and related metrics as needed.
• Ensures documentation management and record keeping are compliant with regulatory expectations and Nuvalent SOPs.
• Develops and maintains knowledge of evolving regulation and FDA guidance and attends relevant training on topics related to the regulation of prescription drug promotion.
• Participates in Regulatory Affairs initiatives aimed at improving the efficiency of advertising and promotion review and submission process.

Competencies

• Excellent attention to detail, focused on quality, interpersonal, collaboration, written, verbal and visual communication skills.
• Experience with Accelerated Approval requirements in managing advertising and promotional material, subpart H pre‑submissions and 2253 submissions.
• Motivated and curious learners with the ability to be resourceful and solve problems.
• Possesses a high degree of professional ethics, integrity and responsibility.
• Exhibits flexibility and is adaptable to change in a fast‑paced environment.
• The ability to multitask, prioritize and work under pressure in adhering to tight deadlines.
• Proven ability to successfully manage projects and timelines, organise/track complex information.

Qualifications

• BS or equivalent and 3‑5 years of related experience.
• Advanced working knowledge of Advertising, Promotion and Labeling regulations, guidance and OPDP expectations.
• Experience with submission requirements for accelerated approval applications.
• Experience with Veeva PromoMats, Microsoft Word, Adobe Acrobat and other electronic review systems.
• Oncology and/or US commercial product launch experience is a plus.

Additional Information

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. The annual targeted base salary range for this role is $104,000 – $128,000. The targeted range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education and market factors. The range will be reviewed regularly and is subject to change. Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health and well‑being journey, including medical, dental and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown) and much more. 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.