Assoc Dir/Dir, Regulatory Affairs Advertising and Promotional Review

Hellocanopy; United States; Remote; USD 170,000 - 230,000; Full time

Job summary

An innovative firm is seeking an Associate Director to Director in Regulatory Affairs. This remote role involves providing strategic guidance on advertising and promotion while balancing regulatory requirements with business objectives. You will collaborate with internal and external stakeholders, ensuring compliance with FDA regulations and supporting a variety of initiatives. Join a dynamic team dedicated to advancing healthcare through innovative solutions and a commitment to excellence. If you thrive in a fast-paced environment and have a strong regulatory background, this opportunity is perfect for you.

Benefits

Medical, Dental, and Vision Insurance

Disability Insurance and Life Insurance

401(k) program with company match

Generous PTO program and holidays

Qualifications

• 5+ years of experience in pharmaceutical/medical device regulatory review.
• Ability to work independently in a remote role with minimal oversight.

Responsibilities

• Provide strategic guidance on advertising and promotion of products.
• Conduct review and approval of advertising and promotional materials.

Skills

Regulatory Review

Strategic Counsel

Project Management

Collaboration

Education

Bachelor’s Degree

Advanced Degree in Science

Job description

Assoc Dir/Dir, Regulatory Affairs Advertising and Promotional Review

Join to apply for the Assoc Dir/Dir, Regulatory Affairs Advertising and Promotional Review role at Canopy Life Sciences.

This range is provided by Canopy Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$170,000.00/yr - $230,000.00/yr

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:

1. 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.
2. 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.
3. 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, advising teams as appropriate.
4. 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.
5. Support a variety of Regulatory Affairs initiatives within the Canopy Life Sciences Regulatory Affairs department related to ongoing process improvement, as assigned.

Qualifications include:

• At least 5 years of pharmaceutical/medical device advertising and promotional regulatory review experience.
• 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 with a generous PTO program and holidays.

Additional details:

• Seniority level: Director
• Employment type: Full-time
• Job function: Consulting