Associate Director, Regulatory Advertising and Promotional Labeling
Nuvalent, Inc.
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
Visit company websiteExplore more
Salary
💰 $175,000 - $205,000 per year
Job Level
About the role
- Reporting to the VP, US Regulatory Advertising & Promotional Labeling, represent Regulatory in the review and approval of prelaunch and post launch promotional activities for U.S. marketed products.
- Contributes to the development and implementation of promotional review strategies.
- Builds and maintains relationships with cross functional representatives of the Promotional Material Review Committee (PMRC).
- Assist in identifying areas of promotional risk and mitigation strategies.
- Serves as Regulatory representative in the Medical Review Committee (MRC) in the review and approval of compliant scientific materials.
- Provides regulatory advice for compliant advertising and promotional materials for launch, marketed and development products.
Requirements
- BS or equivalent and at least 10 years of related experience
- Proficient in Advertising, Promotion and Labeling regulations, guidance, and OPDP expectations
- Experienced in providing regulatory input and evaluation as part of a promotional review committee.
- Experience with Accelerated Approval requirements in managing advertising and promotional material, subpart H pre-submissions and 2253 submissions.
- Experienced with Veeva Promo Mats and other electronic review systems.
- Expertise working with accelerated approval products, oncology and US commercial launch experience is a plus.
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Advertising regulationsPromotion regulationsLabeling regulationsRegulatory inputPromotional reviewAccelerated Approval requirementsSubpart H pre-submissions2253 submissionsOncology expertiseUS commercial launch experience
Soft Skills
Relationship buildingCross-functional collaborationRisk identificationMitigation strategiesRegulatory advice
Certifications
BS or equivalent