Regulatory Affairs Specialist
4 semanas atrás
Embark on a challenging career opportunity as a Regulatory Affairs Specialist at Icon Plc, a leading healthcare intelligence and clinical research organization.
We are seeking an experienced individual to lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
Key Responsibilities:
- Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
- Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
- Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency.
About You:
We are looking for an individual with a Bachelor's degree in life sciences or a related field and minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
Key Qualifications:
- Bachelor's degree in life sciences or a related field.
- Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Fluency in English and Dutch language.
About the Role:
This role is based in [location] and we offer a competitive salary of $85,000 per annum, plus additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
We believe that diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
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