For one of our clients, a big player on the pharmaceutical market, we are currently looking for a "Manager Regulatory Compliance".
Job Description
For a COVID-19 project we are looking for 2 experienced "Regulatory Compliance Managers", with a very good knowledge of English, on a full time basis.
The primary responsibility is to support the regulatory activities related to vaccines in all global markets!
Responsibilities
- Support the regulatory activities related to vaccines in all global markets.
- Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidances related to vaccines.
- Contribute to the preparation and editing of clinical trial and marketing applications
- Correspondence and direct interaction with Health Authorities
- Development of product-specific regulatory strategy documents
- Technical review and approval of master protocols
- Reports and other source documents
Requirements
- Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred.
- Strong knowledge of EU and FDA regulations is required, experience with other markets is added value.
- Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
- Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
- Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader.
Benefits
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
- A 100% home-based position
- COVID-19 Project
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16363
