CMC Regulatory Affairs Manager (m/f/d)

Responsibilities:

• Maintenance of registration files
• Manage post-marketing regulatory activities of chemical pharmaceutical drug products
• Coordinate with partners’ regional regulatory teams for global strategy
• Define, develop and lead regulatory strategies for post-marketing and clinical development activities
• Maintenance and update of the Product Information
• Prepare and review regulatory submissions
• Manage CMC activities
• Internal Regulatory contact for Pharmacovigilance, Marketing and Business
• Maintain policy and regulatory intelligence
• Provide regulatory strategies

Required experience:

• Degree in Science
• 5 years of experience in pharmaceutical regulatory affairs for sterile parenteral chemical drugs
• Experience in regulatory activities for Chemical Pharmaceutical Drug Products (phase I-III)
• Knowledge of ICH Quality Standards, European and US pharmacopoeias, International CMC Guidances, including ASEAN
• Experience in collaboration with health agencies
• Fluent French and English
• Very good attention to details and organizational skills
• Excellent written and oral communication skills