Regulatory Project Manager
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.
RegulatoryProjectManager
ICON plc is a world-leading healthcare intelligence and clinical research organization. Frommoleculeto medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medicaldeviceand government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
The RegulatoryProjectManager collaborates with regional and global crossfunctional 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 RegulatoryprojectManageris responsible forproject 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.
Identifyingoperational risks with projects/submissions, implementing mitigation plans, and managing issues to closure
Responsibilities
Representsthe 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 thetimelyreceipt of submission ready documents for inclusion in global dossiers.
Communicatesexternal agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submission.
Ensures thatcompanyis 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:
Need experience in: Microsoft Project (needed)
Experience supporting BLA’s/IND’s
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:
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
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
