Nuvalent, Inc.
#PreciselyTargetedTherapies for patients with cancer
Associate Director, Regulatory Advertising and Promotional Labeling
Location
Massachusetts
Posted
30 days ago
Salary
$175K - $205K / year
Bachelor Degree10 yrs expEnglish
Job Description
• 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.
Job 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)
