Director, CMC Regulatory Affairs - Biologics (Remote)

ICON; Center Square (PA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Employee assistance program

Work-life balance

Job summary

ICON plc invites a Director, Regulatory Affairs CMC to lead regulatory strategies for Biologics and small molecules, spanning development to post-approval. Location: remote across the US; East Coast preferred; join Global Regulatory Affairs, CMC team.

You will prepare and manage regulatory submissions (INDs/NDAs/BLAs/ANDAs), advise clients, monitor new requirements, and lead quotations and budgeting. Requires experience in US FDA processes, CMC, and biosimilars; RAC certification is a plus.

Qualifications

• Bachelor's in life sciences or healthcare field.
• Advanced degree may be beneficial.
• Regulatory CMC experience in global environment (US/EU/Canada).
• Experience in development and manufacturing of wide range dosage forms.
• Experience supporting business development and people management an asset.
• RAC certification beneficial.

Responsibilities

• Serve as a technical expert in development, testing and manufacturing of Biologics and advise clients.
• Prepare regulatory CMC submission documents for INDs/NDAs/BLAs/NDAs and Post-approval supplements.
• Facilitate submission approvals and amendments through communications with client, government agencies, and project teams.
• Develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.
• Provide clients with strategic advice in response to regulatory queries based on expertise.
• Monitor for new regulatory requirements and share key findings.
• Lead or participate in quotations for projects and manage budgets with change orders.
• Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports.
• Serve as US Agent for client submissions and interface with local agency and sponsor.
• Support preclinical to post-approval activities for client submissions.

Skills

Regulatory CMC

Biologics expertise

Regulatory submissions

US FDA submissions

Client communication

Education

Bachelors in life sciences

Advanced degree beneficial

RAC certification beneficial

Job description

ICON plc invites a Director, Regulatory Affairs CMC to lead regulatory strategies for Biologics and small molecules, spanning development to post-approval. Location: remote across the US; East Coast preferred; join Global Regulatory Affairs, CMC team.

You will prepare and manage regulatory submissions (INDs/NDAs/BLAs/ANDAs), advise clients, monitor new requirements, and lead quotations and budgeting. Requires experience in US FDA processes, CMC, and biosimilars; RAC certification is a plus.