Senior Brand Counsel, Commercial & Regulatory

Psychedelic Alpha; Myrtle Point (OR); On-site; USD 175,000 - 220,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Flexible time off

Equity opportunities

Job summary

Definium Therapeutics seeks an experienced Associate Director, Brand Counsel to serve as a strategic legal partner across Commercial, Medical Affairs, Regulatory, Market Access and Compliance. You will shape the legal and regulatory framework to support development, potential launch and commercialization of Definium assets.

The role requires expertise in pharmaceutical advertising, strong business judgment and the ability to navigate complex regulatory considerations, including FDA, OPDP and

Qualifications

• Active membership in at least one U.S. state bar.
• Minimum of 5 years of legal experience in pharmaceutical/biotechnology industry.
• Demonstrated expertise in FDA-regulated advertising and promotion.
• Experience working within MLR review processes.
• Strong understanding of FDA and OPDP requirements, healthcare fraud/abuse laws, and regulatory launch readiness.

Responsibilities

• Advise on promotions, advertising and promotion strategy for brand assets.
• Act as core member of Promotional Review Committee (PRC) and Medical Review Committee (MRC).
• Review and approve promotional materials directed to healthcare professionals, patients, and caregivers.
• Counsel on FDA, OPDP, FTC and state law requirements applicable to pharmaceutical promotion.
• Support development of governance standards for a pre-commercial organization transitioning to launch.
• Partner with cross-functional teams on risk assessments and mitigation strategies.

Skills

FDA-regulated advertising

MLR review processes

Regulatory launch readiness

Bar admission

Education

J.D. (licensed in US)

Job description

Definium Therapeutics seeks an experienced Associate Director, Brand Counsel to serve as a strategic legal partner across Commercial, Medical Affairs, Regulatory, Market Access and Compliance. You will shape the legal and regulatory framework to support development, potential launch and commercialization of Definium assets.

The role requires expertise in pharmaceutical advertising, strong business judgment and the ability to navigate complex regulatory considerations, including FDA, OPDP and