The Life Science Career Network 

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client, a dynamic bio-pharmaceutical company based in Switzerland, Bern, is looking for two:

Regional Regulatory Affairs Lead/Specialist

on 12-month contract, with possibility of extension afterwards.

Main Responsibilities:

  • Lead Regulatory Initiatives: Act as the Regional Regulatory Lead for the assigned product portfolio and countries, ensuring all activities align with regional and global strategies while meeting local requirements.
  • Dossier Management: Communicate effectively to ensure that dossiers meet regional and local content and format requirements.
  • Documentation Coordination: Compile, track, and coordinate high-quality documentation for submissions, including new license applications and lifecycle activities, to enhance connectivity and improve submission and approval timelines. Address questions related to regulatory submissions.
  • Agency Relationships: Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills to achieve positive outcomes.
  • Cross-Functional Collaboration: Collaborate with internal functions (e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs) to ensure seamless connectivity and regulatory compliance.
  • Stay Informed: Keep abreast of international legislation and guidelines for biological products and related initiatives.

Qualifications & Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required;
  • A degree in Life Sciences, preferably with a post-graduate qualification;
  • At least 3 years of regulatory experience within the international region, supported by additional pharmaceutical/industry experience;
  • Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and principles of GMP and GCP;
  • Proficiency in standard regulatory tools such as Veeva, DocNet, and Trackwise;
  • Ability to attend our client's offices at least 20% of the time.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to vanessa.gilardoni@ctcresourcing.com

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