CMC Project Manager

ICON plc • Blue Bell, SD

1d

About The Position

CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. 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. 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

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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• 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

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Manager