Principal Scientist CMC RA.

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 :

Offer :

Permanent job offer.