Senior Director, Global Regulatory Strategy

Regulatory Jobs; Center Square (PA); Presencial; USD 180.000 - 280.000; Tempo integral

Benefícios oferecidos por esta vaga

Health coverage

Retirement plans

Life insurance

Disability coverage

Employee assistance

Career development

Resumo da vaga

ICON is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy for the organization’s therapeutic area teams and manage a large regulatory staff. You will drive submissions, provide regulatory guidance, and collaborate with cross-functional colleagues to ensure compliant, timely delivery of projects.

You will mentor a large team, support Business Development activities, and represent ICON with regulatory authorities.

Qualificações

• Bachelor’s degree in a relevant scientific discipline or healthcare-related field (advanced degree preferred).
• Extensive experience in regulatory affairs with a track record leading global submissions.
• In-depth knowledge of regulatory guidelines, ICH/GCP, and industry best practices.
• Strong analytical and problem-solving skills; ability to navigate complex regulatory landscapes.
• Excellent communication and negotiation abilities; willing to travel ~25%.

Responsabilidades

• Lead regulatory affairs strategy for ICON's therapeutic area teams; set a clear future direction.
• Collaborate with cross-functional teams to develop regulatory plans and submissions.
• Provide expert guidance on regulatory requirements and global compliance.
• Prepare proposals, bids, and participate in client bid defense meetings; assist triage.
• Represent ICON in interactions with regulatory authorities and inquiries.
• Mentor and develop a high-performing regulatory affairs team.
• Represent Regulatory Affairs in Business Development and generate opportunities.
• Coach and develop others; drive growth and development across the team.
• Understand ICON's global business; help control costs and maximize value.

Conhecimentos

Regulatory affairs

Analytical skills

Communication

Negotiation

Travel willingness

Formação

Bachelor's degree in a relevant scientific discipline

Advanced degree preferred

Descrição da vaga

ICON is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy for the organization’s therapeutic area teams and manage a large regulatory staff. You will drive submissions, provide regulatory guidance, and collaborate with cross-functional colleagues to ensure compliant, timely delivery of projects.

You will mentor a large team, support Business Development activities, and represent ICON with regulatory authorities.