Regulatory Affairs Specialist

Location Leiden
Discipline: Pharmaceutical
Contact name: Sayf Idais

Contact email: s.idais@panda-int.com
Job ref: 16060
Published: 12 days ago

For a big pharmaceutical company, we are looking for a Regulatory Affairs Specialist. The company offers a one-year contract with extension.

The primary responsibility is to

  • 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 guidance related to vaccines. 

 

Additional responsibilities include

  • contribute to the preparation and editing of clinical trial and marketing applications including post-approval changes.
  • 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

  • Min 3 years direct and significant regulatory experience with vaccines and in CMC documentation preparation
  • Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs, and post-approval submissions 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.

 

Location: Leiden

Start date: ASAP

Duration: 1 year + extension

 

ORGANISATION AND OFER

You will join growing and innovative organization and will be involved in successful projects with customers all over the world. You are part of a multi-disciplinary team that is continuously creating value for their clients. This is a unique opportunity to develop yourself and to grow within the company. You can expect an attractive salary, benefits, and a lot of growth within this organization.

 

INTERESTED? Reach out to Sayf Idais for more information by contacting +31 (0)20 20 44 502 or s.idais@panda-int.com