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CMC Regulatory Affairs Responsible

Do you have a solid experience in CMC Regulatory Affairs, and are you looking forward to a long-term mission with broad responsibilities ? At a global pharma company ? Then this is a great opportunity for you!

Job Description

You will be CMC Regulatory Affairs responsible for one or more commercial and/or development small molecule compounds for all markets worldwide.

Responsibilities

  • You will actively participate in several development and other teams
  • Post-approval CMC RA activities will include providing direction on the interpretation and application of global CMC regulations and guidelines for CMC changes including country specific requirements, defining regulatory strategy, writing CMC variation dossiers and coordinating responses to Health Authorities (HA).
  • Development activities will include: contribution to the preparation and editing of clinical trial and initial marketing applications and coordinating responses to HA; correspondence and direct interaction with HA; development of product-specific regulatory strategy documents; technical review and approval of master protocols, reports and other source documents; and other related duties as assigned.

Requirements

  • Direct and significant (8-10 years) CMC regulatory experience with CMC documentation preparation for clinical trials (INDs and IMPDs) and worldwide first registrations (NDA, MAA, NDS…), post approval amendments and variation dossiers for small molecules worldwide.
  • Strong knowledge of EU and FDA regulations is required, experience with other markets is highly preferred.
  • 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 skills, team player, 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 act as an individual contributor, decision maker, and leader.
  • Being fluent in English is a must

Benefits

  • A balanced salary package based on your capabilities and experience, including meal vouchers, etc..
  • Full time position

Existing right to work in Europe required ( please read job spec in full before applying ).

Vacancy number: 17468