MDWerks Inc.

Senior Director – Head of Regulatory Operations, Compliance

MDWerks Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $250,000 - $280,000 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionssubmission formattingpublishing toolsRIMdata governanceworkflow designSOP governanceaudit managementeCTD applicationscompliance tracking
Soft Skills
leadershipteam managementcollaborationcommunicationstrategic planningproblem-solvingtrainingcontinuous improvementoperational efficiencyvendor management