Regulatory Support Specialist (f/d/m)

Cytiva; Kraków; On-site; PLN 90,000 - 130,000; Full time

Job summary

Cytiva, a Danaher company, seeks a Regulatory Support Specialist for its site in Krakow. You will support product managers, regions and customers with quality, regulatory and technical information, shaping regulatory documentation for bioprocess products.

Ideal candidates hold a science degree and 2–5 years in QA or regulatory roles, with strong GMP knowledge and fluent English. Onsite role in Kraków, joining the CRS team committed to accuracy and timely responses.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, or related field.
• 2–5 years in QA, Regulatory, or Product Management.
• Good GMP understanding and regulatory knowledge in bioprocess.
• Excellent written and spoken English.

Responsibilities

• Build regulatory knowledge for bioprocess customers.
• Develop and update regulatory support documents for products.
• Prepare statements and certificates; update guidelines.
• Respond to regulatory issues with investigations and certificates.
• Manage and review regulatory documentation and NDAs.
• Approve customer portal access.
• File and maintain Q&A in databases.

Skills

Regulatory knowledge

GMP understanding

Quality Assurance

Communication skills

English proficiency

Education

Bachelor's degree in Chemistry, Pharmacy or related field

Job description

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. We’re looking for a Regulatory Support Specialist to join Cytiva’s Customer Regulatory Support (CRS) team at our site. This will be an onsite role, based in Krakow. Regulatory Support Specialist is responsible 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 Will Do

• 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.
• 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.
• Approve accesses to customer portals.
• Review and approve NDAs with customers.

Who You Are

• Bachelor of Science degree in Chemistry, Pharmacy or related field.
• 2-5 years of experience from relevant positions within Quality Assurance, Regulatory, or Product Management.
• Good understanding of GMP and knowledge of regulatory requirements in the bioprocess industry.
• Excellent communication skills and fluency in English, both written and spoken.

It Would Be a Plus If You Also Have

• Experience of working in large matrix organizations.
• Fluency in the language of the country of employment.
• Experience in customer communication.

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. For more information, visit www.danaher.com.