CMC Project Manager

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🕒 June 1

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👷‍♀️ Project Manager

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Oversee regulatory affairs delivery • Coach your team and drive continuous improvement • 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 regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients • 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

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • In-depth proven regulatory affairs expertise (EU/APAC) • Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience (US/LATAM/CAN) • 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

🏖️ 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