Sr Manager, Regulatory Labeling and Ad Promo [Remote]

Senior Manager, Regulatory Strategy (Labeling & Ad Promo)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

At ICON, we are looking for a Senior Manager, Regulatory Labeling and Ad Promo who is passionate about making a meaningful impact across the pharmaceutical product lifecycle. In this role, you will support pre- and post-market label development and lifecycle maintenance, provide expert regulatory review of advertising and promotional materials, and contribute to artwork development that supports successful development, marketing applications, and implementation for drugs, devices, and combination products.

Location: US Remote

What You Will Do:

You will provide regulatory labeling and ad promo services, balancing quality, timelines, and stakeholder expectations.

Key responsibilities include:

• Provide regulatory guidance and assistance to internal teams and external clients on labeling, ad promo and artwork related issues
• Manage the creation, review, and approval of labeling documents, including new and revised prescribing information, patient information and packaging
• Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with promotional regulations, corporate standards and policies and business objectives
• Review and approval of promotional materials for assigned products and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines
• Support artwork design (mock-ups, master/commercial/press ready, stability/validation), labeling/packaging components (leaflets, cartons, labels) and artwork review and QC (dieline, fonts, images)
• Ensure compliance with regulatory requirements and standards related to labeling, ad promo and artwork
• Builds and maintains strong collaborative relationships with key internal and external (client) stakeholders, including Global Regulatory leadership team, Safety, Quality, Commercial, Medical Affairs, Advertising & Promotion, Global Development, Legal, Manufacturing, Supply Chain and other functions key to the success of product development and commercialization

Your Profile:

You will have a strong background in regulatory affairs, with proven experience and a commitment to quality delivery.

Required qualifications and experience:

• Bachelor's degree in a scientific discipline or related field
• Minimum of 10 years of experience in regulatory affairs with specific experience in labeling, ad promo and artwork within the pharmaceutical or biotechnology industry

#LI-SB7

#LI-Remote

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply