Bioprocess Regulatory Support Specialist - Life Sciences

Cytiva; Kraków; On-site; PLN 70,000 - 90,000; Full time

Job summary

Cytiva in Kraków is seeking a Regulatory Support Specialist to join the Customer Regulatory Support team onsite. You will provide regulatory and quality documentation, support product managers, regions and customers, and contribute to ensuring compliance for bioprocess products.

The role requires a science degree, 2–5 years in QA/regulatory, GMP knowledge, and strong English communication. Experience in large matrix organizations is a plus.

Qualifications

• Bachelor of Science in Chemistry, Pharmacy or related field is required.
• 2-5 years of experience in QA, Regulatory, or Product Management.
• Good understanding of GMP and regulatory requirements in bioprocess environments.
• Excellent communication skills and fluency in English, written and spoken.

Responsibilities

• Build and maintain knowledge of customers' regulatory requirements for bioprocess products.
• Develop and update regulatory support documentation for regulated products.
• Prepare and deliver statements and certificates; update guidelines and steering documents.
• Respond to regulatory-based issues with investigations and certificate delivery.
• Manage regulatory documentation in databases (RSF, VG, VSF, CCN, certificates).
• Review and approve NDAs with customers.

Skills

Regulatory Affairs

Quality Assurance

GMP

English

Education

Bachelor of Science in Chemistry/Pharmacy or related field

Job description

Cytiva in Kraków is seeking a Regulatory Support Specialist to join the Customer Regulatory Support team onsite. You will provide regulatory and quality documentation, support product managers, regions and customers, and contribute to ensuring compliance for bioprocess products.

The role requires a science degree, 2–5 years in QA/regulatory, GMP knowledge, and strong English communication. Experience in large matrix organizations is a plus.