Bioprocess Regulatory Support Specialist – Kraków (Onsite)

Danaher Corporation; Kraków; On-site; PLN 70,000 - 110,000; Full time

Job summary

Cytiva, a Danaher operating company, seeks a Regulatory Support Specialist in Kraków to join the Customer Regulatory Support team. This onsite role supports Product Managers, regions and customers with quality and regulatory information.

The role requires a BS in Chemistry/Pharmacy or related field, 2–5 years in QA, regulatory or product management, strong GMP understanding, and fluent English. Experience in large matrix orgs is a plus.

Qualifications

• Must have GMP knowledge and regulatory experience.
• Excellent communication skills in English, both written and spoken.
• Experience in customer communication and working in large matrix organizations is a plus.
• Fluency in the language of the country of employment.
• Bachelor’s degree in Chemistry, Pharmacy or related field required.

Responsibilities

• Provide regulatory support to Product Managers, Regions and customers.
• Develop and update regulatory documentation for products in regulated environments.
• Perform investigations and prepare statements and certificates; update guidelines and steering documents.
• Respond promptly to regulatory issues with investigations, documentation, and certificates.
• Manage and maintain regulatory documentation in databases (RSF, VG, VSF, CCN, statements, certificates).
• Approve accesses to customer portals.

Skills

GMP knowledge

Regulatory experience

Customer communication

English fluency

Education

Bachelor of Science in Chemistry, Pharmacy or related field

Job description

Cytiva, a Danaher operating company, seeks a Regulatory Support Specialist in Kraków to join the Customer Regulatory Support team. This onsite role supports Product Managers, regions and customers with quality and regulatory information.

The role requires a BS in Chemistry/Pharmacy or related field, 2–5 years in QA, regulatory or product management, strong GMP understanding, and fluent English. Experience in large matrix orgs is a plus.