Director, Submission Sciences (Regulatory Operations)
About The Position
About This Role The Director of SABR Submissions Sciences is responsible for leading Global Delivery Management (GDM) function: This role is globally accountable for the operational leadership of GDM function. GDM function delivers timely and quality submissions to global regulatory authorities for both major submissions and Lifecycle management. This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for entire GDM function. Cross functional collaboration and building trusted relationships (with Regulatory, Reg CMC, Portfolio Management etc) Leads the planning, preparation, and submission of regulatory documents (e.g., eCTD, IND, NDA) to health authorities, ensuring compliance and strategic alignment. Determines Submission Sciences support model and resource allocation. Supports IT initiatives including acquisitions, divestitures, software upgrades, and new software solutions Develop and manage budgets related to Annual Operating Plan (AOP) including purchase orders and contracts. What You’ll Do Operational leadership for Submission Manager Deliverables: Accountable across the portfolio, ensures that all aspects of global electronic submissions and documents meet regulatory agency and Biogen 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 Annual Operating Plan (AOP). Creates purchase orders and performs invoice review. Drive organizational excellence and process Improvements: Leads Regulatory process improvement initiatives and actively 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 (those planned, as well as those in place) to ensure efficiency and accuracy to driving change, both internally and externally, while maintaining the company’s best interest. People Leadership: Demonstrates leadership within Submission Sciences and GRA and SABR teams while developing each team member by mentoring, providing feedback, seeking opportunities for new experiences, and living the Biogen values. Ensures appropriate and robust training for team members to execute job functions. Manages the day-to-day submission sciences responsibilities, including the overall planning and management of resources to effectively support timely and quality submissions/deliverables to global regulatory authorities. Who You Are The Submission Sciences/Regulatory Operations team at Biogen is searching for an energetic and motivated professional to lead the delivery of timely and quality submissions to global regulatory authorities for both major submissions and lifecycle management.
Requirements
- Bachelor’s Degree (life sciences preferable)
- In-depth, hands-on, experience with industry standard eCTD publishing software.
- 10-15 years hands-on and in a leadership role publishing for IND/CTA/BLA/MDA/MAA for US, EU, and other global markets.
- 10-15 years of experience within Regulatory Operations and publishing Pharmaceutical, Biotechnology, or Life Science industry experience
- SME in ICH, FDA, and EMA guidelines and awareness of evolving regulatory environment
- Experience with Regulatory Processes and Systems
- Ability to lead within matrix and influence without authority through formal channels and informal network
- Financial acumen, with an ability to evaluate budgets, and business case development
- Strong skills in people management
Nice To Haves
- Master’s in relevant discipline preferred
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 Biogen 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.
- Develops and manages budgets related to Annual Operating Plan (AOP).
- Creates purchase orders and performs invoice review.
- Leads Regulatory process improvement initiatives and actively 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 (those planned, as well as those in place) to ensure efficiency and accuracy to driving change, both internally and externally, while maintaining the company’s best interest.
- Demonstrates leadership within Submission Sciences and GRA and SABR teams while developing each team member by mentoring, providing feedback, seeking opportunities for new experiences, and living the Biogen values.
- Ensures appropriate and robust training for team members to execute job functions.
- Manages the day-to-day submission sciences responsibilities, including the overall planning and management of resources to effectively support timely and quality submissions/deliverables to global regulatory authorities.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Director
