Principal Consultant, Labeling Strategy

For more than 30 years, Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of senior-level leaders and innovators provides project-specific contributions or ongoing support through the regulatory process. Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies.

The Principal Consultant, Regulatory Affairs Labeling Strategy 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.
• 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 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.

Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer 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.

As set forth in Opus Regulatory’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.