Associate Director Regulatory Affairs EMEA

vor 1 Woche

Zug, Zug, Schweiz AurigaVision AG Vollzeit CHF 100'000 - CHF 150'000 pro Jahr

For our globally active client, a well-established and innovative biopharmaceutical company with approved products and a very exciting pipeline of novel therapies (pulmonary indications), we are looking for an:

Associate Director Regulatory Affairs EMEA (Ref. 2522)

Zug

As Associate Director Regulatory Affairs, you will be responsible for commercial Regulatory Affairs: Submissions for the EU, filing, tactical operations plan, maintenance, S&Ops, support.

This role does not include direct reports.

Your main tasks

  • Submit Regulatory Files for the EU
  • Handle tactical operations plan
  • Maintenance of dossiers and submissions
  • Develop and execute EMEA regulatory strategies for selected projects in alignment with global plans
  • Represent EMEA Regulatory Affairs in regional and global teams to ensure cross-functional alignment
  • Prepare and manage interactions with regulatory authorities (e.g. scientific advice, PIP submissions, agency meetings)
  • Drive submission of MAAs and post-approval variations for selected projects in the EMEA region
  • Ensure clear communication of regulatory requirements to support timely execution of project activities

Your profile

  • Minimum 4 years of experience in pharma submissions within EMEA
  • broad expertise in
    Pharmaceutical Regulatory Affairs
  • Proven track record in contributing and implementing regulatory strategies
  • Experience in
    planning, preparing
    , and
    submitting original applications and variations
  • Solid knowledge of the
    EMEA and MHRA regulatory landscape,
    especially Health Authority regulations, guidance documents, processes and timelines
  • Strategic mindset with strong critical thinking and problem-solving skills
  • Fluency in English required
  • Team player with the ability to collaborate effectively in a multicultural environment
  • Highly organized, detail-oriented, and committed to delivering clear, accurate results

Tamara Godenzi
is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).

Full discretion is guaranteed and we will gladly answer any additional questions.

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