Principal Consultant Regulatory Affairs, Labeling Strategy

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.

About the role

The Principal Consultant, Regulatory Affairs Labeling Strategy (Manager to Senior Director levels) is primarily responsible for the daily management of regulatory requirements for labeling strategy or labeling operations for one or more projects, designing and implementing labeling strategy, providing leadership to drive labeling consensus, and developing relationships with client subject matter experts and regulatory authorities. We have a robust client portfolio offering a variety of projects across therapeutic areas and regions.

Responsibilities

• Labeling experience across Development, Core, US, EU and Rest of World (ROW) Labeling.
• Understanding of end-to-end labeling process and systems.
• Lead preparation, review, and update content for the development and maintenance of Target Product Label (TPL), Company Core Data Sheet (CCDS), and local labeling and labeling components.
• Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory labeling, process, filing, best practices, etc. in conjunction with client leadership.
• Provide support and guidance to regulatory teams on RA requirements for one or more drug products by evaluating and communicating risks associated with CCDS content updates and implementation strategies.
• Use 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 corporate goals.
• Develop and drive regulatory labeling timelines and deliverables.
• Understanding of labeling governance and process work.
• Support agency requests and documentation process for impact to labeling; participate in agency meetings as requested.
• 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 4 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy.
• 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 labeling submissions and support appropriate regulatory inspections.
• Ability to work independently and innovatively in tackling operational challenges.