Director, Regulatory Affairs - CMC/Biologics

Director, Regulatory Affairs - CMC/Biologics

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.

Director, Regulatory Affairs CMC

Location

The position may be remote based across the US, or East Coast preferred

The Role

As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.

The department is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance.

We are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience.

Responsibilities

• Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues, and clients providing advice
• Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements
• Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.
• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other reso