Back to job search

Manager Regulatory Compliance

  • Location:

    Antwerp

  • Contact:

    Rebeca Martens

  • Job type:

    Contract

  • Contact phone:

    +32 15 28 40 47

  • Industry:

    Pharmaceutical

  • Contact email:

    rebeca_martens@oxfordcorp.com

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