Description
This is an exciting opportunity to join one of the strongest names in the industry as a Regulatory Consultant on an initial 6 month contract basis.You will join their European Oncology Regulatory team, and will be involved in the full lifecycle of assigned therapeutics from development stage to post-approval stage.
The successful candidate will;
- Participate in global regulatory team meetings as appropriate
Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned - Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
- Assist in development of processes related to regulatory submissions
- Draft and review some document content
- Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
- Track dates of submissions and Regulatory Agency responses
Review protocols and ensure alignment with regulatory requirements - Advise team on required documents and submission strategies in preparation of Clinical Trial Applications (CTAs)
- Ensure Clinical Trial Application (CTA) submission packages are complete and available according to agreed timelines
- Review and approve clinical trial supply plans
- Provide regulatory support throughout registration process
- Provide regulatory support throughout life-cycle management
- Advise team on required documents and submission strategies in preparation of Marketing Authorization Applications (MAAs) as assigned (in collaboration with LOCs as appropriate)
- Assist with timely Marketing Authorization Application (MAA) availability, ensure that all document components are in place on time, identify and track critical path activities
- Assist with submission and acceptance of Marketing Authorization Application (MAA)
Experience:
- Relevant life science degree
- Hands on experience in Regulatory Affairs
- Experience with EU markets essential
- Experience in Oncology therapeutics highly desirable
- Strong verbal and written communication skills
- Demonstrated ability to work effectively to project deadlines