Regulatory Project Manager

ICON Strategic Solutions is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. The Regulatory Project Manager will collaborate with cross-functional teams to manage regulatory submissions and ensure compliance with external guidelines and regulations.

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

Requirements:

• 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