Director, Regulatory Affairs – CMC/Biologics

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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

• Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues and clients • Manage preparation of regulatory CMC submission documents for INDs, NDAs, BLAs, NDSs, ANDAs and post-approval supplements • Facilitate submission approvals and amendments through communications and negotiations with clients, government agencies and project teams • Anticipate and develop initial or alternative regulatory strategies • Provide clients with strategic advice based on regulatory experience and area of expertise • Monitor new regulatory requirements and share key findings • Lead or participate in quotations for projects crossing multiple service areas • Manage projects within budget and prepare change orders as needed • Support US FDA drug listing, drug establishment registrations and lot distribution reports • Serve as US Agent for client submissions and interface with local agency and sponsor • Support client submissions from preclinical through post-approval activities

🎯 Requirements

• Bachelor’s degree in a relevant discipline, preferably life sciences or another healthcare field • Relevant pharmaceutical or biologics regulatory experience in a global environment • Experience in technical development, testing and manufacturing of a wide range of dosage forms • Demonstrable experience in a regulatory CMC role or delivering regulatory CMC strategy and documentation during drug development or product maintenance • Experience with small and large molecules, including biologics, biosimilars, CGT, ADCs, vaccines, peptides and radiopharmaceuticals • CMC experience • Experience supporting business development activities and people management is an asset • Certification in regulatory affairs (RAC) or post-secondary institution is beneficial • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary • Performance related incentives • 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 • Professional development opportunities • Reasonable accommodations during the recruitment process