Job Description
Job Description: • Set submission strategy and operational timelines in partnership with Regulatory Strategy and the cross‑functional teams. • Lead the operational planning and execution of global regulatory submissions (INDs/CTAs, NDAs/MAAs, post‑approval lifecycle submissions, HA interactions). • Oversee submission formatting, publishing, QC and archival in accordance with global standards. • Build, evolve, and manage the Regulatory Operations infrastructure, including processes, standards, templates, and best practices. • Own and optimize regulatory systems (RIM, publishing tools, controlled document systems), driving automation and efficiency. • Partner with IT, QA, and system vendors to ensure appropriate lifecycle control for regulated systems. • Maintain submission metrics and compliance tracking, including periodic reviews of archives, submission history, and audit trails. • Lead the creation, implementation, and maintenance of RA SOPs, Work Instructions, and templates to ensure standardization and inspection readiness. • Establish and oversee training on RA procedures and submission standards. • Support inspections/audits, and partner with QA to address inspection findings, ensuring continuous improvement in alignment with quality system principles. • Build and lead a high‑performing regulatory operations team, oversee submission operating model and resource planning. • Manage external vendors (publishing partners, systems providers, CROs) to ensure quality and performance aligned with company expectations. • Partner with Regulatory Strategy to ensure alignment of operational plans. • Serve as a key liaison with CMC, Clinical, PV, and Medical Writing to ensure efficient preparation of submission‑ready content. • Collaborate closely with QA on procedural governance and RA‑related training. Requirements: • Bachelor’s degree in life sciences or related field, advanced degree preferred. • 8 + years in Regulatory Operations with increasing leadership responsibility, and compliance-related responsibilities within RA or other GxP functions. • Proven leadership of submission teams and global submissions, including responsibility for major eCTD applications (e.g., INDs, CTAs, NDAs /MAAs). • Experience implementing or governing RIM, including workflow design, data governance, role‑based security, and integration with publishing tools. • Demonstrated experience leading compliance activities such as SOP governance, audits/inspections, and data integrity programs aligned with electronic records and computerized systems requirements (21 CFR Part 11 and EU Annex 11). Benefits: • medical • dental • vision • time off • 401K • participating in Mineralys incentive plans contingent on achievement of personal and company performance Apply tot his job
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