Senior Director, Regulatory Affairs

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

Benefits offered by this job

Competitive base salary

Incentives

Health coverage

Pension plan

Life & disability coverage

Wellbeing resources

Training & development

Job summary

ICON is seeking a Senior Director, Regulatory Affairs to provide strategic direction and lead regulatory affairs teams globally, steering regulatory strategy for therapeutic area programs and global submissions.

You will mentor up to 80 staff, collaborate with cross-functional teams, interact with authorities, and shape ICON's regulatory strategy and growth opportunities.

Qualifications

• Extensive regulatory affairs experience with global submissions.
• Strong knowledge of ICH/GCP and industry best practices.
• Ability to manage large teams and multi-project portfolios.

Responsibilities

• Lead regulatory affairs strategy for therapeutic-area teams and set future direction.
• Collaborate with cross-functional teams to develop regulatory plans and submissions.
• Guide regulatory requirements and ensure global compliance.
• Represent ICON in interactions with regulatory authorities.
• Mentor a large regulatory affairs team and develop talent.
• Support business development and generate new opportunities.

Skills

Regulatory strategy

Leadership

Regulatory affairs

Communication

Global submissions

Education

Bachelor's degree in a relevant scientific discipline

Advanced degree preferred

Job description

Senior Director, Regulatory Affairs

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.

As a Senior Director, Regulatory Affairs at ICON, you will provide strategic direction and management of Regulatory Affairs teams (up to 80 team members) and projects and contribute to the strategic direction and overall management of the Regulatory Affairs function at ICON strategic solutions.

What You Will Do:

Your focus will be on driving regulatory affairs performance, ensuring quality, and building capability across your area. Key responsibilities include:

• Lead and oversee the regulatory affairs strategy for ICON's therapeutic area teams as a departmental leader, set a clear and convincing future direction, while communicating with clarity.


• Collaborate with cross-functional teams to develop comprehensive regulatory plans and submissions


• Provide expert guidance on regulatory requirements and ensure adherence to global regulations


• Prepare and/or support proposals and bids and attend client bid defense meetings; participate in Triage meetings as required


• Represent ICON in interactions with regulatory authorities, presenting data and addressing inquiries


• Mentor and develop a team of regulatory affairs professionals, fostering their growth and expertise


• Represent the Regulatory Affairs Department in Business Development activities and generate new business opportunities.


• Energizing & Developing Others: Creating an environment that motivates people; Identifies development opportunities for self and others; act as a coach and mentor and share expertise.


• Commercial Awareness: Understanding the ICON business globally; Controls costs and maximizes revenues, margins and added value; Promotes ICON effectively in all interactions.

Your Profile:

You will bring significant regulatory affairs experience, with a track record of building high-performing teams and delivering results.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred


• Extensive experience in regulatory affairs, with a proven track record in leading global submissions


• In-depth knowledge of regulatory guidelines, ICH/GCP, and industry best practices


• Strong analytical and problem-solving skills, with the ability to navigate complex regulatory landscapes


• Excellent communication and negotiation abilities, with the capacity to convey regulatory strategies effectively


• Willingness to travel as required (approximately 25%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives


• Health and wellbeing programmes including medical, dental, and vision coverage where applicable


• Retirement and pension plans


• Life assurance and disability coverage


• Employee assistance programmes and wellbeing resources


• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply