Base: pln 101,250 to pln 168,750 gross; bonus/equi...
Hybrid
Cmc renewals management
Regulatory strategy definition
Data assessment for compliance
The Renewals CMC Team plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use
Job Summary
The Renewals CMC Team plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use.
Key Responsibilities include managing multiple CMC renewals assignments, defining regulatory strategy, and completing data assessment to ensure CMC dossier compliance.
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
The Renewals CMC Team plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use.
Salary
Base: PLN 101,250 to PLN 168,750 gross; Bonus/Equity: eligible for a bonus (if applicable); Benefits: Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus
Skills & Requirements
Must-have
CMC renewals management
regulatory strategy definition
data assessment for compliance
risk identification for submissions
monitoring regulatory intelligence
Nice-to-have
embraces digital transformation
forward-thinking and exploring new possibilities
agile and analytical thinking
supportive & friendly working environment
thrives in a collaborative environment
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
ICH CTD documentation knowledge required
Excellent written and verbal English language communication skills