Director Regulatory Affairs Operations

Job Title / Position: Director Regulatory Affairs Operations



Department: Regulatory Affairs



Purpose of Job




- The Director of Regulatory Affairs Operations will report to the Vice President of Regulatory Affairs and oversee regulatory operations activities across the company’s development portfolio, ensuring that regulatory submissions, documentation, systems, and processes are managed efficiently, consistently, and in compliance with applicable global regulatory requirements.





Major Activities and Responsibilities




- Lead regulatory submission operations for INDs/CTAs, IMPDs, BLAs/MAAs, amendments, supplements, annual reports, briefing packages, orphan drug/designation requests, and expedited program requests
- Develop and maintain submission plans, timelines, publishing schedules, and submission trackers for global regulatory activities
- Serve as a subject matter expert on regulatory submission processes, systems, and electronic submission requirements
- Ensure submissions comply with applicable FDA, EMA, MHRA, and other health authority requirements and electronic submission specifications
- Track regulatory deliverables, milestones, dependencies, risks, and commitments
- Establish and execute standardized processes for submission readiness, document collection, QC, publishing, validation, submission and archival
- Partner with IT and other stakeholders to optimize regulatory systems, workflows, and integrations
- Establish clear roles, responsibilities, and interfaces between Regulatory Operations and other Regulatory Affairs functions
- Lead, mentor, and develop regulatory operations personnel as the organization grows
- Work proactively in a cross-functional organization to help execute effective regulatory strategies in alignment with nonclinical, CMC and clinical development plans and portfolio strategy
- Ensure timely escalation of issues that could affect regulatory submission timelines
- Manage contracted third party providers





Key Performance Indicators




- Maintenance of compliance with product reporting and regulatory documentation requirements
- Contribution to achievement of product developmental milestones through timely execution of regulatory submissions





Key Job Competencies




- Excellent organizational, communication and time management skills
- Ability to set and achieve challenging goals, demonstrate persistence and overcome obstacles and measure self against standard of excellence
- Speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings
- Sensitivity and experience with non-domestic organizations/cross-cultural environments
- External partner management





Qualifications





- Bachelor’s degree in life sciences, health sciences, regulatory affairs, information management, or a related discipline
- 8+ years of experience in regulatory affairs and/or regulatory operations within the pharmaceutical, biotechnology, or related industry
- Significant experience managing regulatory submissions across product development stages
- Strong knowledge of FDA electronic submissions and eCTD requirements
- Experience with global regulatory submissions, preferably including FDA, EMA, and MHRA
- Experience managing submission publishing, validation, and transmission
- Experience with regulatory information management and document management systems
- Demonstrated ability to manage multiple complex projects and competing priorities
- Ability to work effectively in a fast-paced, cross-functional biotech environment