Manager, Regulatory Affairs
Core
Provides project representation and input to drug development projects, ensuring the smooth running of the Regulatory Affairs Department.
Role type
Manager, Regulatory Affairs
Builds
Regulatory submissions and dossiers for drug development
Domain
Pharmaceutical / CRO / Clinical Trials
Required skills
Expert knowledge of ICH GCP and EU Clinical Trials Directive, Expert knowledge of drug development, Leadership and organizational management, Strategic planning and scheduling, Technical documentation preparation (IMPDs, IBs), Compliance with national regulations, Cross-functional communication, Mentoring and line management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide expert regulatory advice and contribute to regulatory project work, Ensure accurate compilation, management and tracking of submissions, Participate in business development activities preparing regulatory sections of proposals, Develop department work practices and company initiatives, Liaise with the Regulatory Affairs Director to plan and submit regulatory submissions, Coordinate and manage regulatory and ethics committee submissions across EMEA, Asia Pacific and Latin America, Review and recommend documentation for compliance with ICH GCP and country specific requirements, Effectively communicate submission status with Sponsors and Project Managers, Provide training, coaching and mentoring to junior staff, Deputise for the Regulatory Affairs Director as required