Note: The job is a remote job and is open to candidates in USA. Opus Regulatory, Inc. is a niche firm providing experts in Regulatory Strategy, CMC, Labeling, Ad Promo and Medical Review. They are seeking several Principal Consultants in Regulatory Affairs Advertising + Promotion to manage regulatory requirements for drug products and provide leadership on advertising and promotional materials.

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 US, EU and ICH regulatory requirements 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

Skills

• 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
• Advanced degree in a science discipline preferred
• Experience across multiple therapeutic areas is highly desirable

Company Overview

• Opus Regulatory is a niche consulting firm headquartered in the Seaport district of Boston. It was founded in 1994, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 51-200 employees. Its website is