Gerente Pl Assuntos Regulatórios
Core
Gerenciar o portfólio regulatório de oncologia, desenvolvendo estratégias para registros iniciais, novas indicações, extensões de linha e manutenção do ciclo de vida de medicamentos na Brasil.
Role type
Senior Regulatory Affairs Manager (Oncology)
Builds
Regulatory submissions and approvals for oncology medicines
Domain
Pharmaceutical industry, Oncology
Required skills
Regulatory strategy, ANVISA interaction, lifecycle management, risk mitigation, stakeholder management, team leadership, cross-functional collaboration, compliance review, market monitoring
Preferred skills
Experience with small molecule synthetic drugs, biologics, antibody-drug conjugates (ADCs), oncology portfolio management
Technologies
ANVISA submission systems, regulatory databases
Responsibilities
Manage oncology portfolio regulatory strategy and timelines; Lead regulatory submissions for new drugs, indications, and line extensions; Conduct strategic interactions with ANVISA; Evaluate opportunities to accelerate approvals; Anticipate and mitigate regulatory risks; Partner with Medical Affairs, Market Access, and other functions; Lead regional and global discussions on Brazilian requirements; Maintain marketed portfolio and manage commitments; Monitor regulatory environment and translate trends into strategy; Review promotional materials for compliance; Represent company in industry associations; Lead and develop the regulatory team
Seniority
Senior, hands-on IC