Regulatory Project Manager - Homebased in UK/Europe

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

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 Submission 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

• 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:

• Strong previous experience in submissions, regulatory operations or publishing.
  
• Strong project management skills - Microsoft Project,  OnePager (preferred to also have experience in), Planisware (would be nice to have)
  
• A relevant educational background 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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

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.