Remote Director, Regulatory Affairs (CMC & Biologics)

Regulatory Jobs; Center Square (PA); Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing programs

Retirement and pension plans

Life assurance and disability coverage

Learning and development opportunities

Job summary

ICON is seeking a Director in Regulatory Affairs CMC to provide expert knowledge on the development, testing, and manufacturing of biologics and small molecules. You will lead regulatory CMC strategies and manage global submission activities across INDs/NDAs/BLAs.

You will interface with clients and government agencies, develop regulatory programs, and oversee project budgets while supporting preclinical to post-approval activities.

Qualifications

• Experience in technical development, testing and manufacturing of biologics and small molecules.
• Ability to develop regulatory CMC strategies for global markets.
• Experience preparing regulatory CMC submissions for INDs/NDAs/BLAs and post-approval Supplements.
• Strong communication and negotiation skills with clients and regulatory authorities.

Responsibilities

• Serve as technical expert in development, testing and manufacturing of Biologics.
• Lead or contribute to regulatory CMC submissions for various regulatory pathways.
• Advise clients with regulatory strategies based on deep CMC expertise.
• Monitor new regulatory requirements and share key regulatory insights.
• Coordinate quotations and manage projects within budget.

Skills

Biologics CMC regulatory experience

Regulatory strategy development

IND/NDA/BLAs submissions

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree beneficial (MSc/PhD/M.D./Pharm.D.)

Job description

ICON is seeking a Director in Regulatory Affairs CMC to provide expert knowledge on the development, testing, and manufacturing of biologics and small molecules. You will lead regulatory CMC strategies and manage global submission activities across INDs/NDAs/BLAs.

You will interface with clients and government agencies, develop regulatory programs, and oversee project budgets while supporting preclinical to post-approval activities.