Job Title:
Regulatory Submissions Project Manager
Location:
United States (Remote)
Job ID:
2025-117449
Department:
Regulatory Affairs (ICON Strategic Solutions)
Job Type:
Full-Time, Remote
Application Contact:
Name: Kala Murphy
Message Option: Available through job platform
View Roles: See other roles managed by Kala
Job Description:
About ICON:
ICON plc is a global provider of outsourced development and commercialisation services, supporting pharmaceutical, biotechnology, and medical device companies. ICON partners with clients to deliver better, faster clinical development solutions powered by healthcare intelligence.
Key Responsibilities:
Lead and manage submission-related operational activities and timelines for global regulatory projects.
Collaborate with cross-functional global and regional teams to ensure regulatory submissions are compliant and timely.
Create and manage detailed project plans for regulatory submissions using tools like Microsoft Project and OnePager.
Lead cross-functional teams through submission preparation, review, and dispatch stages.
Identify potential operational risks and implement mitigation strategies to ensure timely project delivery.
Represent the Regulatory Project and Submission Management (RPSM) team in cross-functional planning initiatives.
Partner with document providers to ensure the timely delivery of submission-ready content.
Monitor and communicate evolving regulatory submission standards, ensuring the company remains compliant and competitive.
Qualifications & Experience:
Education: Bachelor's degree or higher in life sciences or a related field.
Experience: Minimum 5 years in regulatory operations, submissions, or publishing.
Skills:
Proven project management expertise with tools such as Microsoft Project.
Preferred experience with OnePager; knowledge of Planisware is a plus.
Experience in Biologics License Application (BLA) submission processes.
Strong organizational, communication, and stakeholder coordination skills.
ICON Employee Benefits Include:
Competitive salary and performance-based rewards
Annual leave allowances
Comprehensive health insurance packages for individuals and families
Retirement planning solutions
Global Employee Assistance Program (TELUS Health) – 24/7 access to well-being professionals
Life assurance
Country-specific benefits, such as:
Childcare vouchers
Cycle-to-work schemes
Discounted gym memberships
Subsidised transport
Health assessments
More details: ICON Benefits Page
Diversity & Inclusion:
ICON is committed to fostering an inclusive, respectful, and diverse work environment. All qualified applicants will receive equal consideration without regard to race, religion, gender identity, disability, or veteran status.
For accommodation needs during the application process:
Request Accommodations
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