Regulatory Support Specialist (f/d/m)

Radiometer; Kraków; In loco; PLN 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Cytiva in Krakow is seeking a Regulatory Support Specialist to join the Customer Regulatory Support team onsite. You will provide quality regulatory documents and assist Product Managers, Regions, and customers with regulatory requests related to quality, regulatory, and technical information.

Responsibilities include developing and updating regulatory materials, investigations, and issuing certificates, while maintaining comprehensive documentation and coordinating NDAs and customer portal

Competenze

• 2–5 years of experience in Quality Assurance, Regulatory, or Product Management.
• Good understanding of GMP and regulatory requirements in bioprocess.
• Excellent written and spoken English communication skills.

Mansioni

• Build and update regulatory support documentation for products in regulated environments.
• Prepare statements and certificates after conducting necessary investigations.
• Create and update guidelines and steering documents.
• Respond promptly to regulatory queries and document investigations and outcomes.
• File and maintain regulatory questions in databases; review and update RSF, VG, VSF, CCN, statements.
• Approve customer portal accesses and review NDAs with customers.
• Maintain complete documentation of questions and answers.

Conoscenze

QA experience

Regulatory knowledge

GMP understanding

English fluency

Formazione

Bachelor of Science in Chemistry, Pharmacy or related field

Descrizione del lavoro

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.

#LI-MK2 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. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.