Senior Manager, Regulatory System Owner, Global Development Systems

Tarrytown, NY, United States
Oct 24, 2020
Required Education
Bachelors Degree
Position Type
Full time
The Senior Manager, Regulatory Systems Owner is responsible for leading regulatory systems implementations and operations for the Global Development Systems organization. The position requires both technical and operational domain expertise in Global Clinical Development, Regulatory Information Management, Regulatory Operations and health authority guidance, processes and technologies. We are looking for the system owner to partner with Global Development personnel to understand business challenges, propose solutions and provide project leadership. They will provide operational direction, project oversight, and lead change control processes within the Regulatory Operations portfolio. We need an individual with outstanding interpersonal skills. The Regulatory Systems Owner is supported by the Technical System Manager, Operational PM/BA and external vendors and service providers. They will work closely with Business Process Owners, Subject Matter Experts, Training teams and corporate IT.

As a Sr. Manager, RSO, a typical day might include the following:
  • Ensuring day-to-day Run operational support meets business expectations and compliance requirements for the user base of Regulatory Systems.
  • Partnering with the Business Process Owners and GDS Regulatory Business Relationship Managers to implement new systems.
  • Leading system operating committee meetings, system change requests and release management for upgrades to existing systems.
  • Setting business user expectations, project timelines and budgets.
  • Directing outsourced Managed Service technical support vendors.
  • Collaborating with Corporate IT in the management of enterprise systems and the development of standards for governance.
  • Partnering with vendors in staying ahead of technology trends and their applicability to business needs.
  • Functioning as point of contact for global development solutions with team members and functional business units within the organization
This role may be for you if you have:
  • Expertise in R&D business domains and technologies and the ability to analyze business challenges and present technology solutions.
  • The capacity to balance multiple work streams in an environment of ambiguity and changing priorities.
  • Strong business analysis, system design and documentation skills
  • Excellent problem-solving skills
  • Detailed knowledge of SDLC methodologies and CFR Part 11 compliance
  • Solid grasp of Clinical and Regulatory business processes and the Pharmaceutical drug / Biologic development cycle
To be considered for this opportunity you must have:
A minimum of ten years' experience leading IT contractors and staff on critical IT projects from start to finish. Experience supporting and administrating Regulatory systems through Business Analysis, Data Modeling and Information Architecture. Proven knowledge of Regulatory Submission Content Management, Regulatory Publishing, Collaboration Software, Service Management, SOP Management, GxP Validation, and Change Control. Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio) is required. Willingness to travel up to 25%.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.