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Principal Consultant, Labeling Strategy

US

 

About Opus Regulatory:

Founded in 1994, Opus Regulatory (Opus) is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations. Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level of Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients.

 

Location: Remote | Levels: Sr. Manager - Vice President

Role Overview

The Principal Consultant, Regulatory Affairs Labeling 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 include:

  • 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:

  • Minimum experience: 5-10+ years pharmaceutical regulatory affairs experience within Labeling
  • Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred)
  • Experience within many different therapeutic areas as well as labeling operations
  • Global and International experience
  • Proven project management skills to support the planning and coordination of labeling submissions and support appropriate regulatory inspections.
  • Ability to work independently and to be innovative in tackling operational challenges.

At Opus Regulatory, we are committed to pay transparency and equitable
compensation practices. Actual compensation will be determined based on factors such
as experience, education, specialized expertise, geographic location, and internal
equity. In select circumstances, compensation may fall outside of the posted range.

US-Remote Pay Range

$210,000 - $300,000 USD

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.

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How many years of relevant professional experience do you have in the practice area for which you are applying?

How many years of experience do you have in developing early-stage labeling strategy for pharmaceutical or biotechnology products? (Strategy development, road maps, objectives)

How many years of experience do you have in developing or refining Target Product Labeling (TPL). How did you use it to inform a product’s development or regulatory strategy?

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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.

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