(Sr.) Director, Regulatory Affairs (Brazil)

(Sr.) Director, Regulatory Affairs (Brazil) - Detalhes da Vaga. ● ) Director of Regulatory Affairs to lead the development and execution of global regulatory strategies supporting the clinical development and commercialization of innovative therapies. ● This individual will play a key role in regulatory planning, submission strategy, and cross-functional collaboration to ensure successful interactions with global health authorities. ●Responsibilites:Develop and execute global regulatory strategies to support product development, clinical trials, and marketing approvals. ●Provide regulatory guidance to cross-functional teams and ensure alignment with overall development and business objectives. ●Lead the planning, preparation, authoring, and review of regulatory submissions to global health authorities, including the FDA, EMA, and other international agencies. ●Support regulatory submissions across the product lifecycle, including INDs, CTAs, NDAs, BLAs, and MAAs. ●Ensure regulatory documentation is accurate, complete, compliant with global regulatory requirements, and delivered within established timelines. ●Monitor regulatory deliverables, identify potential risks, and proactively implement mitigation strategies to support submission timelines. ●Partner with cross-functional teams, external vendors, and regulatory operations to support submission planning, publishing, and document management activities. ●Contribute to the continuous improvement of regulatory processes, document standards, submission workflows, and regulatory systems. ●Qualifications:Bachelor’s Degree required Master’s Degree in life sciences discipline preferred7+ years experience in drug development and regulatory affairsMust have experience with regulatory submission documents. Requisitos para participar do processo. ● . O que oferecemos.