Pharma Regulatory Affairs Manager 60%

Vor 2 Tagen

Schwyz, Schweiz Doris Fink Recruiting & Consulting GmbH Vollzeit

Our client is a pharmaceutical company in the commercial phase, focused on the late-stage development and commercialization of prescription medications in Europe and Switzerland.

Your next challenge is waiting for you Become part of the team. Apply today

Tasks

Development and Execution of Regulatory Plans

  • Develop and implement regulatory plans aligned with the company’s products and objectives.
  • Prepare and submit regulatory documentation, including approval applications, amendments, renewals, or responses to authorities' inquiries.
  • Ensure that documents from partner companies meet required standards and are submitted on time.
  • Establish and maintain professional relationships with regulatory authorities, including participating in meetings, supporting inspections, and addressing inquiries.

Cross-Functional Collaboration

  • Coordinate regulatory processes with departments such as pharmacovigilance, medical functions, quality assurance, and marketing to ensure consistent outcomes.
  • Support quality assurance teams and responsible personnel in monitoring manufacturing processes, technical requirements, and contract management.
  • Provide guidance and review labeling, advertising, and marketing activities to ensure compliance with national and international regulations.
  • Assess business opportunities from a regulatory perspective and contribute to strategic product development.
  • Implement an accessible and well-organized system for storing regulatory documents.

Continuous Learning and Networking

  • Build and maintain a network with external partners and industry representatives to foster regulatory collaboration.
  • Stay updated on changes in regulatory requirements and legal standards for product development and commercialization.

Reporting

  • Work directly with the regulatory department leadership and provide regular updates.
Requirements
  • Degree in a relevant field such as life sciences or pharmacy (advanced degree preferred).
  • At least 5 years of experience in a regulatory role within the pharmaceutical or biotechnology industry.
  • In-depth knowledge of relevant Swissmedic regulations and the ability to apply regulatory requirements to quality management processes.
  • Proficient in German and English; additional language skills are an advantage.
  • In-depth knowledge of regulatory requirements in Switzerland and ideally other European countries.
  • Proven experience in organizing and implementing complex regulatory projects and liaising with authorities.
  • Strong communication skills and team spirit for collaboration with interdisciplinary teams.
  • Strategic and analytical mindset to develop innovative solutions for regulatory challenges.
  • Ability to prioritize tasks and work efficiently in a dynamic environment.
Benefits
  • 5 Weeks vacation
  • Annual Company Event
  • Bonus payment
  • Company workshops and knowledge exchange
  • Flexible working hours
  • Startup culture
  • Company car (depending on the position)


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