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Job title :
Regulatory affairs expert
Contract type :
Working hours :
Gross remuneration € Yearly
Our client, a world leading clinical-stage biotechnology company, is currently looking for their future VP Head of Regulatory Affairs.
The HRA works at the interface between the company and the regulatory authorities, through the entire life cycle of the medication, from early development to commercialization.
- With the project lead, build the regulatory strategy and plans for the project in the company’s pipeline.
- Provide leadership in implementing registration strategy across relevant groups, including Clinical Development, Preclinical Development, Marketing and CMC.
- Lead and work closely with relevant clinical development, operations, and research personnel to ensure regulatory compliance and consistency with regulatory registration strategy.
- Manage interactions and build positive relationships with all relevant Health Authorities to facilitate timely and compliant submissions and approvals.
- Work closely with consultants and contractors to coordinate publishing, and other submission activities including eCTD preparation.
- Participates in the safety team and coordinates the preparation and submission of periodic safety reports.
- With the quality lead ascertains the compliance of production with ICH-GCP guidelines and other relevant specifications and regulatory guidance.
- Identification and management of external consultants – ascertains the utilization of external advice to cover knowledge gaps.
- Attends training lectures, symposia and conferences in order to maintain up-to-date level of knowledge and expertise.
- At least 10 years of experience in the pharmaceutical / biotech industry and 2 years in regulatory affairs (US or global).
- Specific experience in late-stage development, filing of NDA/MAA and launch readiness.
- Experience in working with FDA and EMA.
- Up-to-date ICH-GCP certification.
- Fluent English.