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iconplc Logo iconplc · IT - Administration

Senior Manager, Regulatory Affairs (Ad Promo)

United States, Raleigh Employment contract · Job Posted June 14, 2026
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Job Description

As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Job Responsibility

  • Participate in provision of regulatory expertise in strategic drug development across multiple areas
  • Take part in preparation of strategic development and submission plans
  • Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally)
  • Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities
  • Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices

Requirements

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience
  • US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry
  • Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction
  • Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail
  • Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize

What we offer

  • 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
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