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Lead Regulatory Strategist – Biologics Manufacturing

4 miesięcy temu

Kraków, Lesser Poland Danaher Corporation Pełny etat

Be part of something altogether life-changing

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Lead Regulatory Strategist – Biologics Manufacturing is responsible to provide regulatory strategy expertise to diverse Cytiva product teams, including chemical/materials requirements and Chemistry, Manufacturing, and Controls (CMC), IMPD, and eCTD Module 3 content, review and strategy relevant to Cytiva products and their applications.

This position is part of the Global Regulatory Compliance team and will be remote. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Develop and contribute to the implementation of strategic regulatory roadmaps for Cytiva products and strategic projects, including a wide array of equipment and genomic medicine (cell and gene therapy) and other development programs.
  • Develop and reviews regulatory dossiers and communications in a global regulatory setting, including preparing eCTD-ready documentation for regulatory filings.
  • Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the regulatory communications and briefing documents, leading the team through meeting preparations and moderating the meeting itself.
  • Identify regulatory risks and propose appropriate mitigations in collaboration with regulatory compliance leaders and the cross-functional team, employing global Cytiva standardized methodologies as appropriate.
  • Act as a subject matter expert and mentor for cGMP/CMC regulatory initiatives across the global team.

Who you are:

  • MS/MEng degree or higher from an accredited institution, PhD/MD preferred.
  • Around 10 years' experience working with global regulatory agencies and health authorities, including US FDA, EU EMA/Competent Authorities, and in other global regions.
  • Around 10 years' experience in Good Manufacturing Practices (GMP) for biologic drug development, with significant Chemistry, Manufacturing and Controls (CMC) and/or ICH module 3 experience with experience in cell therapy and/or gene therapy CMC preferred.
  • Effective communication skills, specifically strong oral and written presentation skills preferred.
  • Ability to work effectively in electronic document management systems, e.g., Veeva vault is a plus.
  • Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred.
  • Excellent written and verbal communication skills; fluent in English (oral and written).
  • Language skills in German will be a great advantage.
  • Proficient in Microsoft Office applications including Word, Excel and PowerPoint.
  • Acts as a strong regulatory business partner that is able to engage with diverse cross-functional matric environment to develop regulatory strategy and drive deliverables.
  • Demonstrated ability to drive change initiatives in a matrix environment. Ability to work independently and leverage the support of others in a fast-paced business environment.
  • Strong communication, interpersonal and problem-solving skills. Skilled influencer, able to communicate complex messages to others.
  • Is able to apply regulatory principles to the business and long-term strategy, builds relationships with stakeholders to ensure Cytiva regulatory goals are met.
  • Strong sensitivity for a diverse multicultural/multinational global environment.
  • Committed to integrity. #LI-remote At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.