Biopharmaceutical Regulatory Specialist
3 days ago
Become a Biopharmaceutical Regulatory Specialist
Cytiva Sverige AB is dedicated to advancing future therapeutics from discovery to delivery, and we're seeking an experienced Biopharmaceutical Regulatory Specialist to join our team. As a key member of our Qualification Services department, you will be responsible for overseeing strategic initiatives that ensure customer regulatory needs are met in our delivered products.
This role requires collaboration with product management to identify product gaps versus customer regulatory requirements, develop business cases for new and updated Qualification Services product offerings, and ensure available product offerings match customer regulatory requirements.
You will also define standard regulatory requirements of Qualification Services products and collaborate with cross-functional teams to implement requirements in new and existing products.
Apart from these responsibilities, you will act as a regulatory expert and discussion partner to cross-functional teams, representing the voice of customer regulatory needs to facilitate risk-based product-related decisions.
Your expertise will support the Business and Customers in a global environment by providing regulatory expertise support in ongoing projects, new product development, change control, and in response to customers' requests for quality, regulatory, and technical-related information as it pertains to Qualification Services products.
To succeed in this role, you must have a Bachelor of Science degree in Engineering, Biochemistry/Chemistry or biopharmaceuticals-related field, with ten or more years of experience in GMP, quality, product management, or a related field.
You must also possess a strong understanding of GMP and regulatory requirements in the Bioprocess industry, including but not limited to 21 CFR Part 11 and EU GMP Annex 11, and have strong written and verbal communication skills, fluent in English.
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