Manager, Regulatory Operations

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.