Base: pln 101,250 to pln 168,750 gross; bonus/equi...
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Cmc regulatory strategy
Regulatory submissions
Ich ctd documentation
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GSK is seeking a Regulatory Specialist to manage Chemistry, Manufacturing, and Controls (CMC) renewals for Pharma and Vaccines products in a hybrid working environment. The role requires relevant experience in regulatory affairs, strong communication skills, and a commitment to digital transformation.
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Job Summary
The Renewals CMC Team ensures Pharma and Vaccines products are safe, effective, and high quality by authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control.
Key responsibilities include managing CMC renewals, defining regulatory strategy, assessing data for compliance, identifying submission risks, and improving regulatory processes.
GSK offers a hybrid working model with flexible hours, opportunities for professional development, and a comprehensive benefits package including medical, life insurance, and retirement programs.
Matching Summary
Match Score: 75
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GSK is seeking a Regulatory Specialist to manage Chemistry, Manufacturing, and Controls (CMC) renewals for Pharma and Vaccines products in a hybrid working environment. The role requires relevant experience in regulatory affairs, strong communication skills, and a commitment to digital transformation.
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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, private healthcare, additional paid days off, fully paid parental leave & care of family member leave
Skills & Requirements
Must-have
CMC regulatory strategy
regulatory submissions
ICH CTD documentation
pharmaceutical industry
regulatory intelligence monitoring
Nice-to-have
adaptability and forward-thinking
digital transformation participation
agile and analytical thinking
supportive working environment
collaboration and relationship building
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
Excellent written and verbal English communication skills