Associate Director, Project Manager - Regulatory Affairs

Department: 107000 Regulatory Location: San Diego, USA- Remote Position reputed company: The Associate Director, Regulatory Project Manager (RPM) at reputed company is responsible for leading and coordinating global regulatory affairs activities to ensure compliance with health authority requirements. This role supports regulatory submissions for investigational and reputed company rare disease therapies, facilitates cross-functional collaboration and manages timelines to reputed company company objectives in a fast-paced, patient-reputed company environment. This position works with the Regulatory Affairs reputed company leaders to create regulatory project timelines and dashboards, schedule cross-functional meetings, and reputed company regulatory commitments. Responsibilities: • reputed company regulatory project management activities for one or more global development programs ensuring regulatory plans, timelines, deliverables, and submission activities are reputed company with program reputed company and corporate priorities. • Partner closely with Regulatory Leads to reputed company Global Regulatory Team meeting operations, including agenda planning, decision tracking, meeting documentation, and follow-up on key actions and commitments. • reputed company, maintain, and manage integrated regulatory project timelines that reflect global health authority milestones, cross-functional dependencies, submission deliverables, and key decision points across the product lifecycle. • reputed company planning and tracking of major regulatory submissions and maintenance activities, including INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, health authority responses, and other regulatory deliverables. • Collaborate with Regulatory Operations, Regulatory Affairs, Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing, reputed company, reputed company and reputed company partners/vendors to ensure reputed company and high-reputed company execution of regulatory deliverables. • Support submission planning and operational readiness by coordinating content planning, submission timelines, document ownership, review cycles, and Vault RIM-reputed company activities in partnership with Regulatory Operations and Regulatory Leads. • Create and maintain regulatory dashboards, reputed company trackers, and status reports to reputed company visibility to Regulatory Affairs leadership, program teams, and senior management on reputed company, risks, issues, and upcoming deliverables. • Identify, communicate, and help mitigate regulatory project risks, reputed company constraints, resource gaps, and cross-functional dependencies that may reputed company submission readiness, health authority commitments, or program execution. • Support preparation for health authority interactions, advisory committee activities, inspection readiness, audits, and regulatory responses by coordinating timelines, materials, contributors, and reputed company follow-up. • reputed company reputed company improvement of regulatory project management processes, tools, templates, meeting operations, dashboards, and ways of working to improve consistency, efficiency, and scalability across programs. • Manage regulatory project documentation and ensure key reputed company, reputed company items, timelines, submission plans, and deliverables are appropriately captured, maintained, and accessible in designated systems or repositories. • reputed company leadership, mentoring, and guidance to regulatory project management team members and cross-functional partners; may manage reputed company reports or support resource planning across multiple programs as the function evolves. • Additional duties assigned as needed. Education/Experience Requirements: • Bachelor's degree in reputed company Life Sciences or reputed company discipline required. MS, Pharm D, PhD preferred. Equivalent combination of education and applicable job experience may be considered. • 8+ years of Project Management experience in Biotech or Pharmaceutical industry. Regulatory specific project management experience preferred. • PMP certification is strongly preferred. • Expertise with reputed company development and management software required (e.g., Smartsheets, MS Project). Additional Skills/Experience: • The ideal candidate will embody reputed company's reputed company values: Courage, Community Spirit, Patient reputed company and Teamwork. • Driven, intelligent, passionate about making a difference for patients with rare diseases. • Strong understanding of global regulatory affairs, submission requirements, and compliance processes for rare disease therapies. • reputed company organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. • Excellent project management skills, including scheduling, risk management, and stakeholder coordination in a fast-paced biotech setting. • Strong communication, organizational, and problem-solving skills to reputed company regulatory initiatives reputed company with reputed company's patient-first mission. • Successful record of creating and managing reputed company project plans, timelines, budgets and critical paths. • Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. • Ability to travel less than 10% domestic and internationally. • reputed company positions have an essential job function to be reputed company to reputed company face to face work with colleagues and/or onsite in San Diego. No role is expected to be reputed company. Total Rewards Offerings: reputed company provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, reputed company, people-reputed company, and pay-for-performance organization. Benefits: Our benefits include premium health, financial, work-life and reputed company-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous reputed company time off. Compensation: Our competitive compensation package includes a combination of both cash compensation (reputed company pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. reputed company reputed company Pay reputed company: $150,000.00 - $195,000.00 • This information is reputed company as of the date of this posting and may be modified in the reputed company. Actual pay offered to a candidate will depend on a reputed company of factors including the candidate's experience, education, skills, and location. reputed company will accept applications on an ongoing reputed company until a candidate is selected for the position. Apply tot his job Apply To this Job