Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Hamburg, Hamburg - Adecco


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Regulatory Affairs Specialist

vor 2 Monaten


Hamburg, Hamburg, Deutschland Adecco Vollzeit

Job Summary

Adecco is seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.

Key Responsibilities

  • Support the preparation of regulatory documents in eCTD format
  • Collaborate with cross-functional teams to ensure compliance with national and international regulatory procedures
  • Develop and maintain regulatory dossiers and ensure their accuracy and completeness
  • Assist in the creation of product information texts and electronic submission forms for EU and US procedures
  • Support the extension, renewal, and update of regulatory approvals and the archiving of regulatory documents using eCTD Manager
  • Perform other quality management tasks as required

Requirements

  • Completed technical or natural science education and initial work experience
  • Familiarity with current legislative and regulatory requirements in the pharmaceutical industry
  • Proficient in MS Office applications and experience with database systems such as eCTD Manager
  • High level of commitment, flexibility, reliability, and teamwork
  • Fluent German and English language skills in writing and speaking

Benefits

  • Opportunity to work in a dynamic and established family-owned company
  • Flexible working hours with core working hours and mobile work options
  • Additional benefits such as bike leasing, travel expense reimbursement, and company pension scheme
  • Adecco will support you throughout the entire recruitment process