Regulatory Systems Strategy Lead (Associate Director/Director)


(Cambridge, Massachusetts)
Full Time
Job Posting Details
About Biogen
Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
The Head of Regulatory System Strategy drives how the regulatory function brings together its technology, processes and people to enable strategic objectives and underpin Regulatory core capabilities. Develops and implements the Regulatory Information Strategy in line with broader organization objectives. Provides oversight and governance of Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information strategy are met. Responsible for analyzing Regulatory IT/technology industry trends and driving best practices across Regulatory and cross functional interfaces. Partner with IT, Business functions and Project Management Office to provide holistic strategy of Regulatory Systems integration, as well as with vendor(s) to influence HA and industry innovation.
* Responsible for developing & evolving the regulatory information strategy in line with regulatory affairs & affected stakeholders, including industry and Health Authority perspectives, to ensure robust future proof processes and systems. * Responsible for overseeing regulatory information quality, reporting and analytics to monitor quality and maximize the use of regulatory information. Includes interface data that is required between different cross functional systems and drives the integration of data and processes from a system perspective * Responsible for developing and implementing a strategy to ensure oversight of system compliance, business value and efficiency in the management and delivery of regulatory information services, leveraging appropriate vendor partnerships. * Represent Biogen at HA/Industry body meetings for regulatory information strategy and influence applicable policies and adoptions of data standards and regulatory technological advancements * Researches forthcoming regulatory guidance revisions and analyses subsequent impacts to internal processes & technology. Communicates impacts to wider business functions, and drives execution in collaboration with stakeholders. * Effectively communicates project status, issues, schedule and accomplishments to regulatory affairs and stakeholder groups, as needed. * Ensures regulatory information strategy is communicated and understood by broader cross functional teams.
Ideal Candidate
**Qualifications** * 10+ years of experience in Pharmaceutical, Bio-Technology, or Life Sciences * Minimum of 5 years in regulatory operations or similar * Leadership experience in implementing innovative systems * Leadership role in Regulatory information management/GxP data * Highly developed Stakeholder Management skills * Strong communication and influencing skills **Education** * Bachelor’s Degree Life Sciences/Business/IT * If Life Sciences degree further advanced qualification in business/IT preferred
Compensation and Working Conditions
Benefits Benefits not included


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