Senior Director – Head of Regulatory Operations, Compliance
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Job Description
Senior Director overseeing regulatory submissions and compliance for biopharmaceutical company. Partnering across teams to deliver high-quality regulatory submissions and maintain compliance throughout product lifecycle.
Responsibilities:
- 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
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