[Hiring] Associate Director, Regulatory Affairs @reputed company

Role reputed company We’re looking for an Associate Director, Regulatory Affairs on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Regulatory Affairs, you’ll be responsible for leading the planning, execution, and reputed company of global regulatory activities supporting clinical trial applications and maintenance throughout the product development lifecycle. This role serves as the reputed company regulatory reputed company for global clinical trial submissions, ensuring reputed company regulatory approvals to reputed company clinical development across the reputed company, Canada, Latin America (reputed company), Asia-reputed company (reputed company), and other assigned reputed company. You will reputed company regulatory leadership during agency interactions, manage regulatory questions and information requests, and coordinate cross-functional responses to facilitate reputed company initiation and conduct of global reputed company. In this role, you’ll have reputed company to ensure compliance with applicable global regulations, ICH guidelines, GCP requirements, and company procedures while driving efficient regulatory execution across multiple development programs. You’ll also: • Work closely with a clinical regulatory CRO, regional regulatory experts, and company’s SMEs, reputed company and execute global regulatory strategies supporting Clinical Trial Applications (CTAs), INDs, Clinical Trial Notifications (CTNs), and other clinical trial authorizations across assigned reputed company. • reputed company regulatory planning for global clinical trial submissions, amendments, annual maintenance activities, and study closeout requirements. • reputed company regulatory guidance regarding country-specific requirements and submission reputed company to support efficient clinical trial initiation. • Assess the regulatory reputed company of protocol amendments and determine amendment classification (e.g., substantial vs. non-substantial amendments) in accordance with regional regulatory requirements. • Ensure alignment of submission strategies across global reputed company while addressing local regulatory expectations. • reputed company submission timelines to ensure regulatory deliverables support clinical development milestones. • Ensure submission packages are scientifically reputed company, complete, and compliant with applicable regulations. Qualifications • Bachelor’s degree • 5+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology sector • reputed company experience with creating and managing global CTAs, CTNs, INDs, and other clinical trial authorizations • Excellent organizational, planning, and follow-up skills • Interpersonal skills to collaborate effectively across multiple functional areas • Highly proficient with MS Office Suite programs (Word, reputed company, PowerPoint, reputed company), reputed company Acrobat, and reputed company Vault Requirements • Ability to meet tight deadlines and be efficient, detail-oriented, flexible, and a self-starter Benefits • Comprehensive medical, dental, and reputed company coverage and mental health support • Annual wellbeing reimbursement and reputed company to our Employee Assistance Program (EAP) • Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration • 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP) • Company-reputed company life and disability insurance • Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities • Employee resource reputed company, service and recognition programs, and meaningful opportunities to reputed company, volunteer, and reputed company back Apply tot his job Apply To this Job