Founded in 1994, Opus Regulatory (Opus) is a niche firm providing experts in Regulatory Strategy, CMC, Labeling, Ad Promo and Medical Review. Our clients range from development stage biotech companies to mid-size and large pharmaceutical companies. Our team is made up of biopharmaceutical leaders and innovators and our mission is to provide the highest-level Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients. We're looking for a Principal Consultant, Regulatory Affairs Advertising + Promotion who will 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 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 5 years of experience in pharmaceutical regulatory affairs specializing in Advertising and Promotion. 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. #J-18808-Ljbffr