Senior Manager, Regulatory System Owner, Global Development Systems
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY, United States
- Start date
- Sep 25, 2020
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- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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
- 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
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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