Director, Submission Sciences – Regulatory Operations
Biogen
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $202,000 - $278,000 per year
Job Level
About the role
- 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.
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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
eCTD publishing softwareIND publishingCTA publishingBLA publishingMDA publishingMAA publishingRegulatory ProcessesRegulatory Systemsbudget evaluationbusiness case development
Soft Skills
leadershipmentoringfeedbackinfluencing without authoritystakeholder engagementorganizational excellenceprocess improvementpeople managementcommunicationteam development
Certifications
Bachelor’s Degree