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.

Associate Director/Director, Regulatory Affairs (Strategy)

At Canopy, our world-class team of dedicated and experienced Regulatory Affairs subject matter experts provide an unparalleled level of customer service to assist clients in meeting complex challenges in an evolving environment of product development and commercialization. With a combination of technical expertise, industry experience and business-focus, our Regulatory Affairs team works closely with clients worldwide to deliver high-quality innovative solutions, setting up our clients for success as they navigate the complex global regulatory landscape. We pride ourselves on our flexibility and can offer ad-hoc coverage, part time coverage to full time coverage.

As we are expanding our Regulatory Affairs team, we are seeking a highly motivated, detail-oriented, experienced Associate Director / Director, Regulatory Affairs (Strategy) . This role will be primarily responsible for assisting pharmaceutical and biotechnology company clients with setting and/or implementing regulatory and submission strategies to advance drug, biologic, cell and gene therapy product development in a variety of therapeutic areas.

Responsibilities include:

Support the development and implementation of regulatory strategies to facilitate the advancement of portfolio programs through early to late-stage clinical development and commercialization.

Represent Regulatory Affairs on cross-functional project teams, providing sound guidance and advice for the resolution of complex project issues and to execute decisions for successful achievement of planned objectives.

Provide strategic planning, management, preparation, and review of regulatory submission documents in collaboration with project teams, subject matter experts, CROs, Regulatory Operations, and external publishing resources to ensure high-quality and timely delivery of submissions to Regulatory agencies.

Regulatory agency interactions, to include the preparation of meeting requests and briefing packages, as well as participation in agency meetings.

Maintain knowledge of shifting regulatory landscape and competitive intelligence.

Qualifications for this position include:

Bachelor’s degree in life-sciences or related scientific discipline, advanced degree preferred.

Minimum of 6 years of experience in Regulatory Affairs strategy.

Demonstrated leadership ability with strong critical thinking, analytical, and problem solving skills required to provide sound guidance and advice, and to execute decisions.

Excellent written and verbal communication skills and the ability build and maintain effective relationships.

Great attention to detail and ability to organize, prioritize, and adapt to changing priorities.

Strategic and operational experience in the management and preparation of a variety of regulatory submissions.

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.