Specialist, Regulatory Affairs
Core
Prepare, submit, and maintain Marketing Authorization applications and variations for pharmaceutical products under supervision.
Role type
Specialist, Regulatory Affairs (Pharmaceuticals)
Builds
New Marketing Authorizations, license renewals, and variations for assigned products
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Regulatory filings, Marketing Authorization applications, Labeling translation, Artwork management, Regulatory intelligence, Compliance documentation, Stakeholder liaison, SOP development
Preferred skills
International Regulatory Compliance, Regulatory Policies, Analytical Thinking, Innovation
Technologies
Artwork Management Systems, Regulatory databases, Digital workplace tools, AI-enabled productivity tools
Responsibilities
Submit new Marketing Authorization applications and variations; Maintain authorized products through renewals and updates; Manage labeling translation and artwork; Liaise with local health authorities and internal stakeholders; Collect regulatory intelligence; Participate in audits and inspections; Support product launches and recalls.
Seniority
Specialist, individual contributor