Regulatory Support Specialist — Biotech & Life Sciences

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

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