Senior Regulatory Project Manager

ICON Strategic Solutions; United States; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Global Employee Assistance Programme

Life assurance

Work-life balance

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization. This role Senior Manager, Regulatory Strategy involves designing and analyzing clinical trials, interpreting medical data, and driving regulatory submissions with cross-functional teams globally.

You will collaborate with regional and global teams to plan, prepare and deliver compliant regulatory submissions, addressing risks and issues to ensure project success in a dynamic client partnership.

Qualifications

• Requires a life-sciences degree or equivalent.
• Experience with regulatory submissions, operations, or publishing.
• Strong project management skills.
• Fluency in English.
• Experience supporting BLA/IND submissions.

Responsibilities

• Represent the regulatory project and submission management group in cross-functional planning to develop global regulatory submission and execution plans.
• Partners with document providers to project manage submission-ready documents for inclusion in global dossiers.
• Communicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in delivery.
• Ensures awareness of external guidelines, regulations, changes in the marketplace for global regulatory projects and submissions.
• Lead cross-functional submission teams from authoring to dispatch and project goal delivery.

Skills

Project management

Fluent English

Regulatory submissions

Education

Life sciences degree

Tools

Microsoft Project

Veeva RIM

Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What You Will Do

As a Senior Manager, Regulatory Strategy at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

The Regulatory Project Manager collaborates with regional and global cross functional teams to plan, prepare and deliver compliant regulatory submissions, providing support to ensure all business deliverables are met.

Working on this exclusive client partnership, the Regulatory project Manager is responsible for project managing submission related operational aspects.

Creating and managing project plans for regulatory projects using input from key stakeholders. Leading and managing cross functional submission teams from authoring to dispatch/project goal delivery.

Identifying operational risks with projects/submissions, implementing mitigation plans, and managing issues to closure

Responsibilities

Your Profile:

• Represents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client’s needs and regulatory team goals.
• Partners with document providers to project manage the timely receipt of submission ready documents for inclusion in global dossiers.
• Communicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submission.
• Ensures that company is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to global regulatory project and submission management.

To Enable Success In This Position You Will Have

• A relevant educational background in a life-sciences discipline Some previous experience in submissions, regulatory operations or publishing.
• Strong project management skills
• Fluency in English
• Need experience in: Microsoft Project (needed), Veeva RIM
• Experience supporting BLA’s/IND’s

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.