Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
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. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The
Lead Regulatory & Compliance Specialist
is responsible for providing analysis, counsel, regulatory support, quality assurance, environment, health and safety, facility security, and emergency response services, and regulatory and compliance technical training services to the organization.
This position reports to the Senior Regulatory & Compliance Manage rand is part of the Cytiva China QARA team.
What You Will Do
- Perform pharmaceutical-relevant regulatory topics presentations in public occasions (including industry conferences, customer sites, etc) on Cytiva's regulatory positioning.
- Direct participation in local customer projects discussion & design (cooperate with the local commercial team for projects).
- Shaping the connection between the regulatory authorities and Cytiva in multiple ways, including Industrial Conference, GMP Inspectors Training, Thematic Research, etc.
- Support the local commercial team on internal training as organizer & trainer.
- Support internal cross-linked activities and projects (including resources coordination/meetings preparation etc.) between commercial and regulatory teams.
- Support internal initiatives as required by the QARA team.
The Essential Requirements Of The Job Include
- Solid experience in drug registration and participation in IND, BLA, NDA, and the drug modification process.
- Experience in GMP inspection and involvement in the drug production process.
- Understand the application of the products from Cytiva.
- Proficient in English.
Travel Requirements
- This role may require up to 50% travel.
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we'll 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.
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