CMC Project Manager

Job title: CMC Project Manager

About the Role ICON is seeking a CMC Project Manager to oversee regulatory affairs delivery, coach your team, and drive continuous improvement. As a CMC Project Manager at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You'll Do

• 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, scientific/agency advice, orphan drugs/pediatric development, medical devices.

What We're Looking For

• You will have a strong background in regulatory affairs, with proven management experience and a commitment to quality delivery.
• Required qualifications and experience:
• 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.

Compensation & Benefits

• 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.