At Mineralys Therapeutics, we are looking for a Senior Director, Head of Regulatory Operations & Compliance to join our Regulatory Affairs team. This is a key leadership role accountable for regulatory submission excellence and the compliance framework across the product lifecycle.
What You'll Do
- Set submission strategy and operational timelines in partnership with Regulatory Strategy and 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.
- 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.
What We're Looking For
- Bachelor’s degree in life sciences or related field.
- 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).
- Deep understanding of regulatory authority submission standards, global HA guidelines, and industry best practices.
- Expert knowledge of eCTD submission models and lifecycle sequencing, familiarity with evolving global standards (including ICH eCTD v4.0).
- Expertise with regulatory technologies (e.g., RIM and eCTD publishing suites).
- Strong grasp of data integrity principles, and quality system expectations.
- Ability to build and scale processes fit for a fast-paced and growing organization.
- Excellent leadership, communication, and cross-functional collaboration skills.
Nice to Have
- Advanced degree preferred.
Team & Environment
This is a key leadership role within Regulatory Affairs.
Benefits & Compensation
- Salary: $250,000 - $280,000
Work Mode
This is a global position.
