Consultor GRC responsável pela implementação de projetos de Governança, Riscos e Compliance na Redbelt Security. Avaliação de processos e controles para segurança cibernética e melhoria contínua.
About the role
- Director, Regulatory Affairs providing leadership in regulatory submissions and cross-functional activities for drug development. Collaborating with biopharmaceutical clients to ensure compliance and excellent delivery in development planning.
Responsibilities
- Provides senior regulatory and integrated project leadership for global drug development projects
- Acts as both Regulatory Lead and Project Lead
- Creates key regulatory submissions and leads cross-functional development activities
- Serves as a trusted strategic advisor and primary point of contact
- Integrates regulatory, clinical, safety, CMC, nonclinical, biostatistical, and commercial inputs
- Delivers coherent, executable development plans across the drug development lifecycle
- Leads preparation for governance forums, internal reviews, and client decision meetings
- Anticipates regulatory and development risks across US and EU projects
- Mentors junior colleagues and Project Leads
Requirements
- Master’s degree in Life Sciences or a related discipline
- Minimum of 8 years of relevant experience
- Significant hands-on regulatory experience across both the US and EU/UK
- Demonstrated experience leading and authoring major regulatory deliverables
- Proven ability to develop and drive regulatory strategy across the drug development lifecycle
- Experience working within global, cross-functional development teams
- Demonstrated experience acting as a cross-functional Project Lead
- Strong capability to lead matrixed, multidisciplinary teams without direct line authority
- Experience managing complex timelines, risks, budgets, and resourcing across multiple functions
- Ability to translate complex regulatory requirements into clear, actionable development strategies
- Strong client-facing skills
- Advanced written and verbal communication skills
- Demonstrated judgment, resilience, and flexibility
Benefits
- commitment to integrity
- diversity, inclusion, and belonging
- professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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