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Assoc Dir/Dir, Regulatory Affairs Advertising and Promotional Review Fully Remote - US

Assoc Dir/Dir, Regulatory Affairs Advertising and Promotional Review

Full Time • Fully Remote - US
Responsive recruiter
 
 
At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team. 

As an Associate Director to Director, Regulatory Affairs Advertising & Promotion, you will provide strategic, expert guidance on the advertising and promotion of assigned products, balancing regulatory requirements with the business needs and objectives of our clients.  Your ability to anticipate challenges, offer innovative solutions, and foster strong relationships with both internal and external stakeholders will be key to your success in this role. 

This is a Remote position. 

Responsibilities include: 

·        Act as the primary Regulatory expert within an assigned client’s Medical, Legal, and Regulatory (MLR) team, providing balanced strategic counsel and tactical support on both commercial and development programs. 
 
·        Conduct solutions-oriented and collaborative review and approval of all advertising and promotional materials, disease-awareness, scientific publications, training, and medical education materials and programs throughout an assigned product’s lifecycle. 
 
·        Maintain up-to-date knowledge of FDA laws, regulations and guidance documents, as well as the compliance environment as it relates to the advertising and promotion of pharmaceutical products and medical devices and advise teams as appropriate. 
 
·        Support the review of proposed updates to package inserts/labeling, offering input on potential promotional messages and claims. Collaborate with teams to help integrate relevant labeling changes into product promotional materials as needed. 
 
·        Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned. 

Qualifications for this position include:

·        At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review. 
·        Ability to work independently in a remote role with minimal oversight.
·        Proven ability to manage multiple priorities simultaneously, maintaining focus and meeting deadlines in a fast-paced environment while balancing diverse tasks and responsibilities. 
·        Strong team-oriented mindset with a collaborative attitude, able to work effectively with internal and external cross-functional teams to achieve common goals and drive successful outcomes. 
·       Bachelor’s degree (advanced degree in a science discipline preferred) 

As a part of our full-time team, you are eligible for our Comprehensive Benefits including:
  •  Medical, Dental and Vision Insurance 
  •  Disability Insurance and Life Insurance  
  •  401(k) program with company match 
  •   A balanced approach to work-life that offers a generous PTO program and Holidays.
 

This is a remote position.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.





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U.S. Equal Opportunity Employment Information (Completion is voluntary)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.