Senior Director, Head of Regulatory Operations & Compliance

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”

Mineralys is a fully remote company.

Senior Director, Head of Regulatory Operations & Compliance

The Senior Director, Head of Regulatory Operations & Compliance, is a key leadership role within Regulatory Affairs, accountable for the regulatory submission excellence and compliance framework across the product lifecycle. This role owns global submission execution, regulatory systems governance (RIM/publishing), and the RA compliance program and inspection readiness. This leader partners closely with Regulatory Strategy, QA, Clinical, CMC, and Medical Writing to deliver high-quality submissions and to maintain compliant, controlled processes and systems.

Key Responsibilities

Submission Management

• 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.

Process & Systems

• 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.

Compliance & Inspection Readiness

• 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.

Team & Vendor Management

• 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.

Cross-Functional Partnership

• 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.

Qualifications

Education & Experience

• 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).

Skills & Competencies

• 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.

Travel Requirements

• This position requires up to 15% travel outside the local area and overnight.

US Salary Range: $250,000 - $280,000

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