Regulatory Operations Manager

Role Summary

The Regulatory Operations Manager will play a critical role in planning, preparing, and managing global regulatory submissions, with a strong emphasis on eCTD publishing and lifecycle management. This individual will ensure submissions are compliant, high‑quality, and delivered on time to global health authorities. The role requires close collaboration with cross‑functional partners—including Regulatory Affairs, CMC, Clinical, and Quality—to support regulatory strategy and execution across development programs.

Responsibilities

• Lead the end‑to‑end planning, coordination, and execution of global regulatory submissions (IND/CTA, NDA/MAA, amendments, supplements, responses to queries, and annual reports).
• Develop and maintain submission timelines, deliverable trackers, and communication plans to ensure alignment across functional teams.
• Serve as the primary internal point of contact for submission‑related activities and issue resolution.

• Prepare, compile, and publish electronic submissions in eCTD format in accordance with regional requirements (FDA, EMA, Health Canada, PMDA, and other global authorities).
• Manage submission lifecycle activities, including sequence planning, metadata management, and archive maintenance.
• Ensure submissions meet all technical standards, validation criteria, and regulatory guidance.

• Maintain up‑to‑date knowledge of global electronic submission standards, regulatory requirements, and industry best practices.
• Oversee document formatting, QC, and version control to ensure accuracy and consistency.
• Support inspection readiness and contribute to continuous improvement of regulatory operations processes, templates, and systems.

• Partner closely with Regulatory Strategy Teams to support and ensure alignment on submission content and timelines.
• Work with Product Development (CMC and Device), Clinical, Manufacturing, Nonclinical, and Quality teams to coordinate document delivery and resolve content or formatting issues.
• Provide guidance to authors on document standards, templates, and submission expectations.

Qualifications

• Required: Bachelor’s degree preferably in a scientific or technical discipline.
• Required: 7+ years of experience in Regulatory Operations within the pharmaceutical or biotechnology industry.
• Required: Demonstrated expertise in global eCTD publishing, including hands‑on experience with major publishing tools and validation software.
• Required: Strong understanding of global regulatory requirements and electronic submission standards (FDA, EMA, ICH, etc.).
• Required: Proven ability to manage multiple submissions and deadlines in a fast‑paced environment.
• Required: Excellent organizational skills, attention to detail, and communication abilities.

• Preferred: Experience supporting major submissions such as IND, NDA, BLA, or MAA.
• Preferred: Familiarity with regulatory information management systems (RIMS) and document management systems (DMS).
• Preferred: Knowledge of emerging global electronic submission requirements (e.g., eCTD 4.0).
• Preferred: Prior experience in a mid‑sized or rapidly growing biotech/pharma environment.
• Preferred: Project management training or certification.