[Remote] Regulatory Project Manager
Note: The job is a remote job and is open to candidates in USA. 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 plan and deliver compliant regulatory submissions, while managing project plans and operational aspects related to submissions.
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
Skills
- 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
- Experience supporting BLA's/IND's
Benefits
- 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
Company Overview