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CMC Regulatory Affairs Manager

m/w/d, Wallis

For our client we are looking for an exeprienced CMC Regulatory Affairs Manager who provide expert content guidance for quality portions of the CTD, ensuring compliance of documentation to internal company standards and external regulatory guidelines.

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