Regulatory Submissions Project Manager

March 19

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ICON plc

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ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.

Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes

10,000+ employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• 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.

🎯 Requirements

• 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

🏖️ Benefits

• 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