Manager, Regulatory Advertising & Promotion Submissions

The Role:

Reporting to the VP, US Regulatory Advertising & Promotional Labeling, the Manager, Regulatory Advertising & Promotion Submissions will utilize Veeva Promo Mats 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.
• Attend regularly scheduled submission plan meetings and collaborate with Commercial Operations and Project Owners in formulating and adhering to planned submission schedules.
• Track 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 promotional material eCTD submissions.
• Maintains a thorough understanding of OPDP submission requirements.
• Generate submission reports and related metrics as needed.
• Ensures documentation management and record keeping are compliant with regulatory expectations and Nuvalent SOPs
• Develop and maintain knowledge of evolving regulation and FDA guidance and attend relevant training on topics related to the regulation of prescription drug promotion.
• Participate in Regulatory Affairs initiatives aimed at improving the efficiency of advertising and promotion review and submission process.

Competencies Include:

• 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, organize/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.