About This Role:

As the Head of Regulatory Information Management (RIM) you will manage the RIM team, drive data quality, deliver RIM technology roadmaps (in partnership with IT), ensure regulatory standards (XEVMPD/IDMP), and process efficiencies across Global Safety and Regulatory Sciences (GSRS).  You are responsible for the RIM strategy in line with broader organizational objectives and provide overall governance over the Regulatory systems and related business processes, including Regulatory Master Data Management (MDM), and Regulatory Business analytics.  The role will be responsible for Biogen engagement across industry bodies and with Health Authorities (HA) to lead, influence and drive development of related standards and strategies.

What You’ll Do:

• Leads the planning, development, and execution as the business driver, sponsor, and critical decision maker for the major Regulatory-IT capability related projects.  Provides strategic guidance, program level issue escalation resolution, business resource triaging at the program and/or executive committee levels.
• Responsible for the current and future state of Regulatory Information Management (RIM), leading the business, and identifying new technologies to meet the demands of a rapidly changing industry.  Leads the technical strategies that integrate with other initiatives (e.g. Master Data Management, Product Hub), the broader R&D Roadmap, and maximizes the effectiveness of the overall RIM ecosystem.  Communicates and drives the changes both internally and externally to enable the adoption and implementation of industry best practices.
• Direct People leadership of team to include performance management and development of team members.  Manage the day-to-day RIM operations and overall planning and management of RIM operations resources to effectively deliver the enabling capabilities across GSRS.
• Provide the centralized business admin function across Regulatory systems, monitoring and enforcement of RIM data compliance, centralized data services within RIM capabilities (support of regulatory “events” in GRIT, BEAMS, etc.)  and to enterprise capabilities (Clarity, etc.), supporting MDM operations across Regulatory
• Provide the centralized business intelligence (BI) and analytics requirements across RIM.  This entails the development, implementation and evolution of the standard reporting and publishing of Regulatory Information, managing the MDM framework on behalf of GSRS
• Using expert knowledge of RIM and Regulatory Systems to lead translation of related Global Health authority guidelines/regulations (IDMP, etc.) for Biogen stakeholders and ensuring clear / relevant communication.   Represent Biogen on industry associations: lead, influence and provide input to intelligence/policy initiatives in alignment with internal and external stakeholders, ensuring a focus on Biogen’s interests.

Who You Are:

In addition to having excellent written and communication skills, you have successfully worked in a matrix environment demonstrating ability to collaborate and influence. You have proven experience leading a RIM or similar regulatory function at a mid to large global biotech or pharma company.  You have robust global, health authority experience (inspections/other interactions) and have a strong understanding of regulations across GCP, GVP, GRP and GLP

Required Skills

• 10+ years of experience of experience in Pharmaceutical, Bio-Technology, or Life Sciences

• 5+ years’ experience in a leadership role in Regulatory Information Management (RIM) or related regulatory function - working knowledge of Biopharma development and approval process, including related HA laws and regulations

• 5+ years’ experience managing & developing people and functions

• 5+ years of proven Customer and Business Relationship Management roles/skills

• Recognized leader across industry, HA, and vendors driving industry best practices and Regulatory capability innovation.

• Leadership experience in implementing innovative systems with deep familiarity on industry best practices and capabilities across Regulatory Processes and Systems. 

• Leadership role on multiple significant business/system project delivery (>$1M). 

• Proven networking ability and change management experience

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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.

The base compensation range for this role is $170,900.00 to $284,700.00. 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.