Regional Regulatory Lead

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16079en
  1. Contract
  2. English
  3. Associate
  4. Legal, Regulatory & Compliance
  5. Zurich, Bern
  6. Healthcare & Life Sciences

Skills

Regulatory affairs, Lead, pharmaceutical, GMP, GCP, Veeva, DocNet, Trackwise

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On behalf of our client, an international biopharmaceutical company, Swisslinx is looking for a Regional Regulatory Lead. If this is you, you will serve as Lead for the assigned product portfolio and countries.

Contract type: initially 12 months, extension very likely
Start Date: 1st August
Location: Bern OR Zurich, Switzerland
Workload: 100%
Work type: hybrid, 20% on site in either Bern or Zurich

Your mission:
• Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area: Immunology, Respiratory, Transplant) and countries.
• Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements.
• Communicate effectively to ensure that dossiers meet regional and local content and format requirements.
• Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions.
• Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes.
• Collaborate with internal functions (e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs) to enhance connectivity.
• Stay informed about international legislation and guidelines for biological products and related initiatives (e.g., rare diseases, orphan drugs).

Your background:
• 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 understanding of the principles of GMP and GCP.
• A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
• Proficiency in standard regulatory tools: Veeva, DocNet, Trackwise.
• Fluent English language ability.

What's on offer
• A 12 month contract at an internationally-renowned biopharma company.
• A competitive salary.
• A flexible hybrid working policy.

If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.

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