Job Description

About Opus Regulatory:

For more than 30 years, Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of senior-level leaders and innovators provides project-specific contributions or ongoing support through the regulatory process. Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies.

We're looking for a Principal Consultant, Regulatory Affairs Advertising + Promotion, who will primarily be responsible for the daily support or management of regulatory requirements for one or more drug products, providing leadership on advertising and promotional materials, and developing and maintaining relationships with key client staff and regulatory bodies. We have a robust client portfolio offering a variety of projects including therapeutic areas.

Responsibilities include:

Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership.
Provide strategic and operational leadership for promotional, educational, and investigative communications
Review and evaluate materials submitted by client teams to ensure that the content, quality, and format comply with applicable laws, regulations, and client policy.
Uses extensive knowledge of country specific regulatory requirements (US, EU and ICH) and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support clients' corporate goals.
Manage launch preparation of promotional material for one or more products.
Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
Maintain knowledge of changing regulatory requirements and advise teams as appropriate.
Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.

Qualifications:

Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Advertising and Promotion.
Bachelor's degree required; Advanced degree in a science discipline preferred.
Experience across multiple therapeutic areas is highly desirable.
Demonstrated global and international experience is required.
Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections.
Ability to work independently and innovatively in tackling operational challenges.

Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.

Opus Regulatory

Open Positions

Principal Consultant, Advertising & Promotion Strategy