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. 

Title: Associate Director, US Regulatory Advertising & Promotional Labeling

 

The Company:

With deep expertise in chemistry, Nuvalent is creating selective medicines 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:

Reporting to the VP, US Regulatory Advertising & Promotional Labeling, the Associate Director US Regulatory Advertising & Promotional Labeling will 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. Maintains knowledge of applicable laws and guidance for prescription drug promotion.

Builds and maintains relationships with cross functional representatives of the Promotional Material Review Committee (PMRC) to ensure effective communication & efficient review of promotional activities. 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.

Responsibilities:

 

• Provides regulatory advice for the development and approval of compliant advertising and promotional materials and activities for launch, marketed and development products, disease state education, field training, and other external communications.
• Provides strategic input, as well as preparation and execution of branded promotional material submissions to the Office of Prescription Drug Promotion (OPDP) that are compliant with applicable laws and regulations, as required.
• Develop working relationships with OPDP staff as necessary pertaining to the promotion of products especially those subject to accelerated approval requirements.
• Maintains a thorough understanding of OPDP requirements as well as knowledge of enforcement trends and provides analysis to review teams.
• Contributes to the development or modification of Regulatory advertising and promotion policies/procedures that affect immediate operations and may also have company-wide effect.
• Ensures documentation management and record keeping are compliant with regulatory expectations and Nuvalent SOPs
• Maintains knowledge of relevant evolving regulation and FDA guidance.
• Conducts periodic training on topics related to the regulation of prescription drug promotion.

 

Competencies Include:

• Excellent interpersonal, collaboration, written, verbal and visual communication skills.
• Motivated and curious learner with the ability to innovate, analyze, and solve problems,
• Ability to anticipate and identify regulatory risks and make recommendations as appropriate.
• Possesses a high degree of professional ethics, integrity, and responsibility.
• Exhibits flexibility and is adaptable to change in a fast-paced environment.
• Collaborate effectively with cross-functional colleagues at all levels including Medical, Legal and Commercial partners.
• The ability to multitask, prioritize, and work under pressure in adhering to deadlines.
• Proven ability to successfully manage projects and timelines, organize/track complex information.

 

Qualifications:

• 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.

 

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

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