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This job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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.
As a Regulatory Affairs Specialist for Cytiva within our Customer Regulatory Support Team, you will be located in Kraków (this will be an on-site position). You will contribute to our success by providing support to our customers. You will ensure that all the required quality/regulatory support documents and subscriptions of regulatory documents are in place and provided to our customers. As a member of our Team, you will add value to BioProcess products and demonstrate commitment to customer satisfaction.
At Cytiva, our vision is to advance future therapeutics from discovery to delivery.
What you will do:
Respond efficiently and promptly to customers regulatory based issues, which will include preparations and delivery of certificates, use of available internal and external databases and other relevant databases.
File and maintain complete documentation of questions and answers in databases; specify, prepare and update regulatory support documentation, including RSF (Regulatory Support Files), VG (Validation Guides), VSF (Validation Support Files), CCN (Change Control Notifications), statements, certificates and other regulatory related documentation for existing products.
Daily management of CRS (Customer Regulatory Support) queue in SFDC (Salesforce) case management.
Review of subscribers of regulatory support documentation.
Who you are:
Bachelor of Science in Chemistry, Biotechnology, Pharmacy or equivalent educational background.
Fluent in English and Polish, written and spoken.
Quality minded, collaborative, and customer oriented with excellent written and verbal communication skills.
It would be a plus if you also possess previous experience in:
Knowledge of regulatory requirements in Pharma/MD/Life Science industry.
High ability to work independently and cross-functionally within global teams.
#Li-onsite
Join our winning team today. Together, well accelerate the real-life impact of tomorrows 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.
For more information, visit www.danaher.com.
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.