[Hiring] Principal Consultant, Advertising & Promotion Strategy @Opus Regulatory

Role Description

We're looking for several Principal Consultant, Regulatory Affairs Advertising + Promotion roles (Associate Director to VP levels) 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.

• 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.
• Use 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.

Requirements

• US-Remote Pay Range: $230,000 — $300,000 USD

Benefits

• Comprehensive benefits package designed to support health, financial well-being, and work-life balance.
• Medical, dental, vision, and prescription drug coverage for employees and their eligible family members.
• Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP).
• 401(k) plan.
• Paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.

Company Description

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.