Regulatory Project Manager
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AI Summary
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.
Regulatory Project Manager
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and 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 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
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)
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:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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
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