Opis stanowiska podany przez pracodawcę:

Job Tasks:

• Collaborate with global teams to lead Regulatory CMC activities supporting product development
• Develop and implement global CMC regulatory strategies for drugs, devices, vaccines, and gene/ cell therapies
• Prepare and review regulatory dossiers for Health Authority submissions
• Collaborate on global submission plans aligned with local regulatory requirements
• Participate in due diligence and licensing evaluations.
• Ensure compliance with company standards and update strategies based on new data
• Communicate effectively with Health Authorities and maintain strong professional relationships
• Identify and escalate risks related to product registration and regulatory compliance
• Review regulatory documents throughout the product lifecycle
• Provide regulatory guidance on chemistry, manufacturing, and control changes

Requirements:

• Degree in biological, pharmaceutical, chemical, or engineering sciences with 8+ years of relevant experience; advanced degree is a plus
• Strong regulatory knowledge and ability to communicate requirements effectively
• Solid background in biology, chemistry, or engineering related to pharma
• Proven experience in creating and implementing regulatory strategies
• Excellent communication and teamwork skills
• Experience working with Health Authorities
• Familiarity with global regulatory frameworks and submission procedures
• Understanding of competitor landscape in product development

Offer:

• Opportunity to work for a global Big Pharma company
• Stable job environment
• Join an international, dynamic team and contribute to innovative projects in global markets
• Option for 100% remote work within Poland
• Work primarily in English 

Permanent job offer. 

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