Regulatory Labeling Strategy Principal

Dennis Partners; United States; On-site; USD 240,000 - 275,000; Full time

Benefits offered by this job

Quarterly bonus program

Comprehensive employee benefits

Remote work flexibility

Job summary

A niche regulatory consulting firm is seeking a Regulatory Labeling Strategy Principal Consultant to manage and execute labeling strategies for biotech and pharmaceutical clients. This remote position offers a competitive salary between $240,000 and $275,000, along with comprehensive benefits. Candidates should have a scientific background, a minimum of 6 years in regulatory affairs, and a deep understanding of U.S. and EU regulations. Occasional travel for client meetings is expected.

Qualifications

• Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy.
• Understanding of end-to-end labeling process and systems.
• Experience with CCDS, SmPC and USPI.

Responsibilities

• Daily management of regulatory requirements for labeling strategy for one or more client projects.
• Design and implement labeling strategy and provide leadership for consensus.
• Lead preparation, review, and update content for labeling components.

Skills

Pharmaceutical regulatory affairs expertise

Labeling strategy development

Project management skills

Knowledge of US and EU regulations

Collaboration with clients

Education

Bachelors in a scientific discipline

Advanced degree (MS, MD, PharmD, or PhD)

Job description

Our client is a niche Regulatory consulting firm which provides the highest-level Regulatory expertise to a variety of biotech and pharmaceutical clients. They are seeking a Regulatory Labeling Strategy Principal Consultant who can provide Labeling strategy and execution for client projects. You will be responsible for the daily management of regulatory requirements for Labeling and serve as a subject matter expert. This is a remote role where you will work closely with exciting biopharma clients and collaborate internally with a team of biopharmaceutical leaders and innovators. This company offers a competitive salary, comprehensive employee benefits, and the ability to work from home. Now is an exciting time to join this dynamic and growing organization!

Responsibilities:

• Daily management of regulatory requirements for labeling strategy for one or more client projects.
• Design and implement labeling strategy, and provide leadership to drive labeling consensus.
• 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.
• Develop relationships with client subject matter experts and regulatory authorities.
• 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 other global 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.
• 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:

• Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred.
• Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy.
• Labeling experience across Development, Core, US, EU and Rest of World (ROW) Labeling.
• Understanding of end-to-end labeling process and systems.
• Must have experience with CCDS, SmPC and USPI. Experience with TPL/TLP is highly desirable.
• Understanding of labeling governance and leading a Label Working Group (LWG).
• Experience across multiple therapeutic areas is highly desirable.
• Demonstrated global and international experience is required.
• Some experience with Labeling Operations a plus, but not 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.
• Must be collaborative and work well with clients.

This is a remote position with some occasional travel for client meetings. The budgeted salary range for this position is $240,000 to $275,000 plus a quarterly bonus program and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.