- Build and maintain knowledge and understanding of customers' regulatory requirements related to the BioProcess business at a high level
- Develop and update regulatory support documentation for products in customers' regulated environments
- Perform necessary investigations and prepare and deliver statements and certificates
- Participate in creating and updating guidelines and steering documents
- Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions
- Participate in project teams as regulatory support expert
- Lead cross-functional activities when required
- Respond efficiently and promptly to customers' regulatory based issues, which will include necessary investigations, 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, update and review regulatory support documentation, including RSF, VG, VSF, CCN, statements, certificates and other regulatory related documentation for new and existing products
- Use existing web based system and expand regulatory supporting information provided on the web
- Bachelor of Science degree in Chemistry, Pharmacy or other related field
- Three or more years of experience in quality, product management, R&D, or a related field
- Understanding of GMP and knowledge of regulatory requirements in the bioprocess industry
- Organized, accurate, target oriented, quality minded and customer oriented
- Strong written and verbal communication skills
- Flexible and service-minded with the ability to be collaborative
- Strong ability to work independently, drive
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Regulatory Support Manager - Uppsala, Sverige - Danaher
Beskrivning
Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry 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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Regulatory Support Manager will have responsibility for providing support to Product Managers, Regions and customers by providing quality documents and regulatory support in response to customers' requests for quality, regulatory and technical-related information. As a member of the Customer Regulatory Support team, you will add value to bioprocess products and demonstrate a commitment to customer satisfaction.
What you ́ll do:
Who are you:
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.
Användare av yrket Regulatory Support Manager i Uppsala
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Milana Adams
Experienced and driven Financial Advisor with over five years of experience providing clients with o ...