Director, Regulatory Affairs – CMC/Biologics

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Act as a technical authority in the development, testing, and manufacturing of Biologics, serving as a resource for ICON colleagues and clients.

• Oversee the preparation of regulatory CMC submission documents for INDs, NDAs, BLAs, NDSs, ANDAs, and post-approval supplements.

• Facilitate the approval of submissions and amendments by engaging in communication and negotiations with clients, government agencies, and project teams.

• Anticipate and formulate initial or alternative regulatory strategies.

• Provide clients with strategic guidance rooted in regulatory expertise and experience.

• Monitor evolving regulatory requirements and disseminate key insights.

• Lead or take part in project quotations that span multiple service domains.

• Oversee projects to ensure they stay within budget and prepare change orders as necessary.

• Assist with US FDA drug listing, drug establishment registrations, and lot distribution reports.

• Act as the US Agent for client submissions, liaising with local agencies and sponsors.

• Support client submissions throughout all phases from preclinical to post-approval activities.

⛳️ Requirements

• Bachelor’s degree in a relevant field, ideally in life sciences or another healthcare discipline.

• Experience in pharmaceutical or biologics regulatory affairs within a global context.

• Background in technical development, testing, and manufacturing across a variety of dosage forms.

• Proven experience in a regulatory CMC role or in delivering regulatory CMC strategy and documentation during drug development or product maintenance.

• Familiarity with small and large molecules, including biologics, biosimilars, CGT, ADCs, vaccines, peptides, and radiopharmaceuticals.

• CMC experience is essential.

• Experience in supporting business development initiatives and managing personnel is advantageous.

• Certification in regulatory affairs (RAC) or from a post-secondary institution is a plus.

• Legal authorization 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 programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Professional development opportunities.

• Reasonable accommodations available during the recruitment process.