Job Summary

• The Renewals CMC Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control for Pharma and Vaccines products.
• Key responsibilities include managing CMC renewals, defining regulatory strategy, completing data assessment, and identifying submission risks.
• The company offers a hybrid working model, flexible working hours, and a wide range of benefits including a medical plan, life insurance, and an employee retirement program.

Matching Summary

Salary

Base: PLN 101,250 to PLN 168,750 gross; Bonus/Equity: Eligible for bonus and/or awards for exceptional performance; Benefits: Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus, statutory benefits, private healthcare, additional paid days off, fully paid parental leave & care of family member leave

Skills & Requirements

Key Requirements

• Min. bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields
• 1-2 years of relevant experience in regulatory affairs
• Familiarity with post-approval CMC regulatory procedures
• Familiarity with ICH CTD documentation
• Excellent written and verbal English communication skills

Work Rights