Regulatory Submissions Project Manager

As a Regulatory Submissions Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

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

Working in this exclusive client partnership, the Regulatory Submission Manager is responsible for managing submission-related operational aspects, including:

• 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.
• Representing the Regulatory Project and Submission Management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans aligned with the client’s needs and regulatory team goals.
• Partnering with document providers to ensure the timely receipt of submission-ready documents for inclusion in global dossiers.
• Communicating external agency submission standards and internal business submission processes to ensure compliance and efficiency in submission delivery.
• Ensuring the company remains aware of and responsive to external guidelines, regulations, market changes, and other factors related to global regulatory project and submission management.

You Are: 

• At least 5+ years of relevant experience in submissions, regulatory operations, or publishing.
• Strong project management skills, with proficiency in Microsoft Project; experience with OnePager is preferred, and familiarity with Planisware is a plus.
• A relevant educational background, such as a BA or higher in a life sciences discipline.
• Experience in BLA submission.

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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.

https://careers.iconplc.com/reasonable-accommodations

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.