Analista Assuntos Regulatórios SR
Core
Managing regulatory registration of new, innovative, generic, and biological medicines, ensuring product compliance, and supporting product launches and B2B activities.
Role type
Senior Regulatory Affairs Analyst (Pharmaceuticals)
Builds
Regulatory submissions and product compliance documentation for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Pharmaceutical registration processes, internal controls management, legal deadline adherence, promotional material evaluation, SOP (POP) maintenance, regulatory inspection support, stakeholder engagement with Anvisa
Preferred skills
Advanced English proficiency, Office Suite proficiency
Technologies
Office Suite
Responsibilities
Managing registration of new, innovative, generic, and biological medicines; Ensuring product compliance and post-registration activities; Managing internal controls and legal deadlines; Supporting product launches and B2B products; Evaluating and approving promotional materials; Maintaining and complying with area SOPs; Participating in meetings with Anvisa and professional entities; Supporting internal and external audits and inspections; Participating in internal training sessions
Seniority
Senior, hands-on IC
