Senior Regulatory Consultant

  • Leeds
  • Proclinical

Senior Regulatory Consultant - Remote - Contract Proclinical is actively seeking a Senior Regulatory Consultant. This is a remote contract position.Primary Responsibilities:This role primarily involves providing regulatory CMC support for post-approval submissions for commercial products, with a focus on biotechnology products. The successful candidate will also be involved in new international MAA filings, predominantly in the EMEA region. This position reports to the Executive Director.Skills & Requirements:Proficiency in generating global regulatory strategy documentsProven leadership skills, with experience leading a team of authors to generate regulatory contentStrong knowledge of regulatory legislation and CMC guidance in EU, US, and ICH marketsExperience with international MAA and post-approval filingsFamiliarity with regulatory submissions for biotech productsExperience with Agency interaction is preferredThe Senior Regulatory Consultant will:Provide regulatory CMC support for post-approval submissions for commercial productsLead a team of SME authors to generate variation/supplement content for regulatory approvalsDevelop global regulatory strategy documentsParticipate in international MAA and post-approval filings