Director, Submission Sciences (Regulatory Operations)

Role Summary

The Director of Submission Sciences leads Global Delivery Management (GDM) to deliver timely and quality regulatory submissions to global regulatory authorities for major submissions and lifecycle management. This role provides strategic leadership, optimizes resource allocation, and drives operational excellence across the GDM function. It involves cross-functional collaboration with Regulatory, Reg CMC, Portfolio Management, and oversight of the planning, preparation, and submission of regulatory documents (eCTD, IND, NDA). The role also defines the Submission Sciences support model and resource allocations, and supports IT initiatives and budgeting.

Responsibilities

• Operational leadership for Submission Manager Deliverables: accountable across the portfolio, ensures that all aspects of global electronic submissions and documents meet regulatory agency and submission standards and technical requirements.
• Demonstrates expert knowledge of submission or technology-related Global Health authority guidelines/regulations.
• Interacts with regulatory authorities for technical inquiries.
• Responsible for operating model, project assignments, and work allocations.
• Financial responsibilities: develops and manages budgets related to the Annual Operating Plan (AOP). Creates purchase orders and performs invoice review.
• Drives organizational excellence and process improvements: leads regulatory process improvement initiatives and engages stakeholders across the enterprise.
• Responsible for the current and future state of submission sciences, influencing business and identifying new technologies to meet the demands of a rapidly changing industry.
• Develops technical strategies that maximize the effectiveness of the systems (planned and in place) to ensure efficiency and drive change, both internally and externally, while maintaining the company’s best interests.
• People leadership: demonstrates leadership within Submission Sciences and GRA and SABR teams; mentors, provides feedback, seeks opportunities for new experiences, and aligns with company values.
• Ensures appropriate and robust training for team members to execute job functions.
• Manages day-to-day submission sciences responsibilities, including overall planning and management of resources to effectively support timely and quality submissions/deliverables to global regulatory authorities.

Qualifications

• Required: Bachelor's Degree (life sciences preferable) with hands-on experience using industry-standard eCTD publishing software.
• Required: 10-15 years hands-on and in a leadership role publishing for IND/CTA/BLA/MDA/MAA for US, EU, and other global markets.
• Required: 10-15 years of experience within Regulatory Operations and publishing.
• Required: Pharmaceutical, Biotechnology, or Life Science industry experience.
• Required: SME in ICH, FDA, and EMA guidelines and awareness of evolving regulatory environment.
• Required: Experience with Regulatory Processes and Systems.
• Required: Ability to lead within matrix and influence without authority through formal channels and informal networks.
• Required: Financial acumen, with the ability to evaluate budgets and develop business cases.
• Required: Strong skills in people management.

Education

• Master’s in relevant discipline preferred