Aktuelle Jobs im Zusammenhang mit Compliance and Risk Management Director - Visp - Lonza Biologics Porriño SLU


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Compliance and Risk Management Director

vor 1 Woche


Visp, Schweiz Lonza Biologics Porriño SLU Vollzeit

As a key member of our team, you'll play a crucial role in shaping our regulatory strategy and driving business growth. In this role, you'll lead a team of professionals dedicated to ensuring our operations meet the highest standards of regulatory compliance.

Your responsibilities will include:

  • Managing a team within a hybrid matrix setup that supports multiple sites and technologies.
  • Serving as a key connector between local teams and regional/global regulatory leadership.
  • Collaborating with Regional Regulatory Experts and Leads to implement harmonized regulatory strategies across all locations.
  • Providing regulatory input for new business opportunities, mergers, acquisitions, and site expansions.
  • Acting as the primary regulatory interface for Growth Project Teams, ensuring compliance considerations are integrated early.
  • Aligning closely with the Global Regulatory Affairs Lead for Advanced Synthesis and RA leads from other sites to create a scalable regulatory affairs framework.
  • Driving process efficiencies that improve speed-to-market while maintaining compliance.

You'll work closely with internal and external stakeholders to prepare high-quality CMC submissions that meet the requirements of FDA, EMA, and other significant regulatory bodies. Your expertise will be essential in overseeing the regulatory CMC aspects of programs, providing guidance, managing preparation, and ensuring submission of CMC documentation supporting clinical trial applications and marketing submissions.

We're seeking an experienced professional with a deep understanding of the pharmaceutical and biotechnology industries. A degree in Regulatory Affairs, Chemistry, Biology, Biochemistry, Pharmacy, or equivalent is required. You'll need excellent communication and writing skills, fluency in English, and a proactive problem-solving attitude. We value collaborative team players who can excel in a dynamic, cross-functional matrix environment.