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Key Responsibilities
- Provide operational leadership and accountability for global regulatory submissions across all application types
- Translate regulatory strategies into executable submission plans, timelines, and resource models
- Oversee teams and external vendors responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers
- Define, own, and maintain submissions-related SOPs, work instructions, job aids, and best practices to ensure consistent execution across programs and regions
- Drive continuous improvement of submission processes to reduce cycle times, increase predictability, and improve quality
- Ensure alignment of submission processes with Quality systems and inspection-readiness expectations
- Partner with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners to ensure seamless handoffs across the submission lifecycle
- Provide operational guidance and training to cross-functional contributors involved in submissions
- Advance cross-functional initiatives that support broader Regulatory Operations objectives
- Lead, mentor, and develop a submissions-focused team
Qualifications
- Demonstrated experience in a senior regulatory operations or submissions leadership role within the pharmaceutical or biotechnology industry
- Deep working knowledge of global regulatory submissions processes and requirements across multiple application types
- Experience overseeing regulatory publishing and managing external submission vendors
- Strong understanding of eCTD standards and submission lifecycle management
- Proven ability to develop and implement SOPs, submission standards, and process improvement initiatives
- Experience operating in a fast-paced, dynamic environment with evolving priorities
- Proficiency in Smartsheet or similar project tracking tools preferred
- Regulatory publishing capability; ability to serve as backup publisher a plus