CMC Project Manager

ICON Strategic Solutions; United States; On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme

Flexible optional benefits

Job summary

ICON Strategic Solutions is looking for an experienced professional to oversee and drive regulatory affairs operations. You will manage regulatory expertise in drug development and play a crucial role in business development activities.

The ideal candidate will have a background in regulatory affairs, with at least 7 years of experience. ICON offers competitive benefits, focusing on well-being and work-life balance.

Qualifications

• Minimum of 7 years regulatory affairs experience.
• Demonstrable experience with regulatory strategies and document writing.
• Strong interpersonal skills and attention to detail.

Responsibilities

• Oversee regulatory affairs delivery and drive continuous improvement.
• Participate in strategic drug development and submission plans.
• Represent the Regulatory Affairs Department in business development.

Skills

Regulatory affairs expertise

Strong organizational skills

Excellent written and verbal skills

Problem-solving ability

Education

Bachelor's degree in a relevant scientific discipline

Job description

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.

What You Will Do

Your focus will be on overseeing regulatory affairs delivery, coaching your team, and driving continuous improvement.

Key Responsibilities Include

• 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.

Your Profile

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: 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 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 specialised 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, subsidised travel passes, health assessments, among others.

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.