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Regulatory Support Specialist
3 weeks ago
Cytiva is a leading life sciences company that partners with customers across the globe to help them solve their most complex challenges.
Job Description:We are seeking a highly skilled Regulatory Support Manager to join our Customer Regulatory Support (CRS) team at our site in Uppsala.
As a member of the CRS team, you will be responsible for providing quality documents and regulatory support to Product Managers, Regions, and customers in response to their requests for quality, regulatory, and technical-related information.
Your key responsibilities will include:
- Becoming a subject matter expert on customer regulatory requirements related to the bioprocess business at a high level.
- Developing and updating regulatory support documentation for products in customers' regulated environments.
- Performing necessary investigations and preparing and delivering statements and certificates.
- Participating in creating and updating guidelines and steering documents.
The ideal candidate will have a strong understanding of GMP and knowledge of regulatory requirements in the bioprocess industry. You should also possess excellent communication skills and fluency in English, both written and spoken.
This role offers an exciting opportunity to work in a dynamic and collaborative environment where you will have the chance to make a real impact on our customers' success.
You will thrive in this role if you are organized, accurate, and target-oriented, with a strong focus on quality and customer service.