Principal Consultant Regulatory Affairs, Advertising and Promotion

Responsibilities

• 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.

Pay

Compensation is commensurate with experience.

Schedule

Full-time position.

Benefits

Opus Regulatory offers a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. This includes 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.