Senior Specialist Regulatory Affairs (Oncology)
Core
Ensure timely preparation and submission of new Marketing Authorization applications and maintain regulatory status of oncology products with Mexican Health Authority (Cofepris).
Role type
Senior Specialist Regulatory Affairs Manager (Oncology)
Builds
New product registrations, variations, renewals, and lifecycle management for pharmaceutical products
Domain
Pharmaceutical / Oncology / Regulatory Affairs
Deliverable
client delivery
Required skills
Oncology product knowledge, Cofepris regulatory expertise, Marketing Authorization submission, variation management, post-approval change management, labeling and artwork compliance, regulatory strategy development, stakeholder negotiation, SOP development, GMP inspection coordination
Preferred skills
Biological/biotechnological/small molecule experience, English proficiency, project management, process improvement
Technologies
Artwork Management System, regulatory databases
Responsibilities
Lead approval process for new MA applications, manage regulatory authority queries, execute variations and renewals, maintain regulatory files and archives, implement SOPs, coordinate with Quality and PV teams, represent company in industry task forces
Seniority
Senior, hands-on IC