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Responsible for defining and implementing global CMC regulatory strategies for a large pharma portfolio throughout clinical development and product lifecycle. This includes managing high-quality regulatory filings and negotiating with health authorities like the FDA to ensure submission approval.
Requires a bachelor's degree in a scientific discipline and extensive experience in global pharmaceutical or biotechnological drug development. Candidates must have proven expertise in authoring regulatory submissions and interacting with global health authorities.
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.
As a Senior Regulatory CMC strategy manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs team at ICON this is a fixed term contract initially until 31st March 2027.
The Senior Manager, CMC Strategy is responsible for global CMC regulatory strategies and activities for a large Pharma portfolio through clinical development, market launch and product lifecycle management.
The successful candidate will provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally.
You will have solid regulatory affairs experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
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.
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.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
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