Bioprocess Regulatory Support Pro

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

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.