What are the responsibilities and job description for the Principal Consultant, Advertising & Promotion Strategy position at Opus Regulatory?
Founded in 1994, Opus Regulatory (Opus) is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations. Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level of Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients.
Multiple Openings | Associate Director–VP Experience Levels
Opus Regulatory's Advertising & Promotional Strategy (Ad Promo) Practice is hiring Principal Consultants to support life sciences clients across a variety of projects, products, and therapeutic areas.
In this role, you will combine strategic regulatory guidance with hands-on execution, helping clients navigate advertising and promotional requirements throughout product development, launch, and commercialization. As an embedded member of client teams, you will lead regulatory review, advise cross-functional stakeholders, and build strong relationships with client leadership and regulatory authorities, as appropriate.
We welcome candidates with experience at the Associate Director through Vice President levels who enjoy solving complex regulatory challenges and contributing directly to client success.
Key Responsibilities
Serve as a regulatory advertising and promotion expert within client teams, advising on strategy, requirements, processes, submissions, and best practices.
Provide strategic and operational leadership for promotional, educational, and investigational product communications.
Review advertising, promotional materials, and other communications for compliance with applicable laws, regulations, guidance, and client policies.
Partner with cross-functional stakeholders to develop clear, actionable recommendations that support business objectives and regulatory compliance.
Lead regulatory planning and review of promotional materials for product launches and ongoing commercialization.
Apply knowledge of U.S. and relevant international regulatory requirements to development programs and marketed products.
Monitor evolving regulatory requirements and advise client teams on their implications for communications, materials, and strategy.
Represent regulatory affairs in client meetings and workstreams, manage project priorities, and support related regulatory initiatives.
Qualifications
6 years of pharmaceutical regulatory affairs experience specializing in advertising and promotional strategy.
Bachelor's degree required; an advanced degree in a scientific discipline preferred.
Demonstrated ability to provide both strategic counsel and hands-on regulatory support for advertising and promotional activities.
Global or international regulatory experience required; experience across multiple therapeutic areas highly desirable.
Strong project management skills, including the ability to coordinate regulatory deliverables, submissions, and competing priorities.
Strong communication and collaboration skills, with the ability to build trusted relationships and translate complex requirements into practical guidance.
Ability to work independently, exercise sound judgment, and develop creative solutions to regulatory and operational challenges.
At Opus Regulatory, we are committed to pay transparency and equitable
compensation practices. Actual compensation will be determined based on factors such
as experience, education, specialized expertise, geographic location, and internal
equity. In select circumstances, compensation may fall outside of the posted range.
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.
Salary : $230,000 - $300,000