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, Global Regulatory Affairs leading Protara's ex-US regulatory strategy and operational execution for clinical studies in oncology, cell and gene therapy, and rare diseases.
Responsibilities
- Lead Protara’s ex-US regulatory strategy and operational execution for clinical studies in oncology, cell and gene therapy, and rare diseases.
- Provide interpretation of regulatory authorities’ feedback, policies, and guidelines.
- Lead the development of study level regulatory strategic plans.
- Own the preparation of major clinical submissions required for regulatory approval.
- Work with program and study teams to resolve complex project issues.
- Ensure compliance with regulations and program timelines.
- Provide interpersonal support and lead personnel.
- Critical thinking, leadership, assertiveness, negotiation and project management skills.
- Oversight of CROs in the management of ex-US CTAs/INDs towards clinical trial activations.
Requirements
- Excellent written and verbal communication skills along with an MD, Ph.D., or Pharm D. degree.
- A minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience.
- 8–12+ years of regulatory affairs experience in the biopharmaceutical industry.
- Demonstrated success interacting with the FDA, EMA and other global health authorities for oncology, cell and gene therapy, or rare disease programs.
- Hands‑on experience leading IND submissions and regulatory meetings.
- Strong understanding of CMC, nonclinical, and clinical requirements for advanced biologics.
- Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships.
- Proficiency in MS Office Suite, with advanced skills in Excel.
Benefits
- Competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.
- Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
- Company-wide dedication to profoundly impacting patients’ lives.
- Amazing culture whereby our core values and behaviors are shared cross-functionally.
- Flexible working hours/schedule.
- Generous Paid Holidays and Unlimited PTO.
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