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Salary
About This Role
The Global Delivery Management Lead is responsible for the oversight and direction of the Global Delivery of regulatory submissions to global health authorities, as well as ensuring the needs of US, EU, and BIR markets are included in the global strategy for each program. This includes the strategic direction of global dossier creation and the subsequent regional rollout of dossiers. Oversees the timelines associated with delivery of submissions including marketing applications. Drives programs in the relevant regulatory systems in line with the Global Delivery model to ensure late stage and lifecycle models are seamless and efficient. Drive the operational excellence message and influence the wider submission community on process efficiency and effective delivery. Oversees submission delivery with outsourcing partner. Leads and supports continuous improvements efforts.
What You’ll Do
- Lead delivery of global submissions including oversight of coordination of US, EU, and BIR deliverables with vendor and US, EU, and BIR strategic plan.
- Create global submission dossier and ensure consistency and quality of submission deliverables across all programs. Provide expertise on global dossier development and submission management.
- Develop and maintain of global submission deliverable plan for submissions for each program.
- Drive strategy to ensure long term operational success. Provide oversight of day-to-day submission science related activities performed by vendor(s) to ensure vendor compliance and quality (e.g., define KPIs, performance metrics)
- Expert for global health authority guideline/regulation and direct intelligence/policy initiatives in alignment with internal and external stakeholders, including industry bodies. Support the evolution of business systems and processes as appropriate, including driving governance and standards.
- Drive execution excellence throughout delivery management team, mentor and build team capabilities in dossier and delivery management
Who You Are
The Submission Sciences/Regulatory Operations team at Biogen is searching for an energetic and motivated professional to support the delivery of timely and quality submissions to global regulatory authorities for both major submissions and lifecycle management.
Qualifications
Required Skills
- Subject Matter Expert in eCTD, global submission guidelines
- 10-15 years of experience within Regulatory Operations
- Pharmaceutical, Biotechnology, or Life Science industry experience
- Experience with Regulatory Processes and Systems
- Strong communication and project management abilities in global and virtual teams
- Bachelor’s Degree (life sciences preferable, IT/Business acceptable)
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Additional Information
The base compensation range for this role is $135,000 to $235,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
