Regulatory Affairs Advertising and Promotion Strategist

7 days ago


Danbury, Connecticut, United States Canopy Life Sciences LLC Full time
Job Overview

We are seeking a seasoned Regulatory Affairs professional to join our team at Canopy Life Sciences LLC. As an Associate Director to Senior Director, Regulatory Affairs Advertising & Promotion, you will play a key role in ensuring the compliance of assigned products with FDA regulations and guidelines.

About the Role

This is a remote position offering a unique opportunity to work in a dynamic, fast-paced environment. You will be responsible for providing strategic guidance on advertising and promotion, balancing regulatory requirements with business needs and objectives.

Key Responsibilities
  • Regulatory Expertise: Act as the primary Regulatory expert within an assigned clients Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on commercial and development programs.
  • Advertising Review: Conduct solutions-oriented review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials throughout an assigned products lifecycle.
  • Compliance Knowledge: Maintain up-to-date knowledge of FDA laws, regulations, and guidance documents, advising teams as appropriate.
  • Labeling Support: Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims.
Requirements
  • Regulatory Experience: At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review experience.
  • Independence: Ability to work independently in a remote role with minimal oversight.
  • Prioritization: Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment.
  • Collaboration: Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams.
What We Offer
  • Compensation: $120,000 - $180,000 per year, depending on experience.
  • Benefits: Comprehensive benefits package including Medical, Dental, and Vision Insurance, Disability Insurance, Life Insurance, and a 401(k) program with company match.
  • Work-Life Balance: Generous PTO program and Holidays.

This is a remote position.



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