Director – Regulatory Affairs, Advertising & Promotions
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Plainsboro • New Jersey • United States
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Salary
💰 $187,000 - $300,000 per year
Job Level
About the role
- Provide strategic regulatory advice on advertising and promotion for assigned products
- Develop and maintain positive rapport and working relationships with Regulatory Affairs, Legal, Commercial, and other cross-functional stakeholders
- Establish strong and positive working relationship with OPDP reviewers
- Assess risk and advise on mitigation strategies to meet overall business need
- Maintain up-to-date knowledge of laws, regulations, and policies enforced by Federal and State governments
- Apply regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives
- Advise on the development of product messages and materials across multiple functional areas
- Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk
- Collaborate with Regulatory Affairs colleagues to provide input to study designs or US labels
- Play a critical role in pre-launch and launch activities as necessary
- Serve as a primary regulatory advertising and promotion reviewer for assigned products
Requirements
- Bachelor's degree in a health- or science-related field and/or an advanced degree
- A minimum of 11 years of pharmaceutical/biologics industry experience required
- 6 years of promotional review experience preferred
- Experience with promotion of a product with conditional approval (Subpart H) highly preferred
- Ability to establish sound working relationships with individuals possessing different levels of skill and background is necessary
- Excellent communication and leadership skills are essential
- Ability to effectively communicate business issues across all levels of the organization, negotiate business decisions, evaluate risk, and work toward solutions
- Experience and knowledge of current FDA requirements; experience handling interactions with FDA
Benefits
- medical, dental and vision coverage
- life insurance
- disability insurance
- 401(k) savings plan
- flexible spending accounts
- employee assistance program
- tuition reimbursement program
- voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
- time off pursuant to its sick time policy
- flexible vacation policy
- parental leave policy
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory advicepromotional reviewrisk assessmentFDA regulationsproduct messagingstudy design inputlaunch activitiesconditional approvaltherapeutic area knowledgebusiness negotiation
Soft Skills
communicationleadershiprelationship buildingcollaborationproblem-solvinginterpersonal skillsorganizational skillstrainingnegotiationevaluating risk
Certifications
Bachelor's degreeadvanced degree