Director, Business Partner-Drug Safety/Regulatory Affairs

Jul 17, 2017
Jul 19, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

  • Responsible for driving the strategy and delivery of systems capabilities for Regulatory Affairs and Pharmacovigilance / Risk Management.
  • Serve as the primary Systems Business Partner by translating business needs into delivery of technology capabilities.
  • Ensure that technology capabilities are effectively identified, implemented and utilized in GCP and non-GCP environments
  • Provides and supports tools and reports for the management of information.
  • Accountable for understanding the business needs, priorities and challenges of Regulatory Affairs (RA) and Pharmacovigilance / Risk Management (PVRM) to establish the strategy for delivering system and service capabilities.
  • Align systems and service strategies with business goals and objectives to insure business outcomes are realized.
  • Translate those needs into effective and/or improved processes and/or technical solutions or services by coordinating resources from within their function or the associated IT Department(s)
  • Accountable for the delivery of business cases and prioritization across the portfolio
  • Accountable for the management of supply and demand of IT resources.
  • Understands internal RA and PVRM processes, plans, objectives, drivers, and issues, together with external policies and regulations to insure compliance and effective solution / service delivery
  • Accountable for the evaluation of technology solutions favoring cloud and buy over build and ensure appropriate configuration of technologies to meet Regeneron business needs
  • Accountable for the execution and governance of the RA and PVRM IT portfolio and budget
  • Prepares the IT budget, coordinates with the Program Management Office and IT Finance as needed.
  • Accountable for the communications with the all business stakeholders.
  • Serves as a Subject Matter Expert in routinely briefing key stakeholders on different aspects of assigned initiatives.
  • Accountable for Plan components of the Software Development Life Cycle including
  • Insuring the business outcome is understood
  • Documentation of requirement (business, functional, and technical)
  • Planning for Go live support and business readiness
  • Partner with IT vendors in keeping abreast of technology trends and applicability to business needs.
  • Introduce new innovative technologies to the business.
  • Participate in industry peer groups to understand industry trends.
Supervisory Responsibilities:
  • To be determined based on experience and qualifications of applicant
BS/BA Degree with 15+ years relevant experience. MS degree and 12+ years relevant experience.
  • Experience managing IT capability identification, selection and implementation in Early Clinical Development, Biostats, Statistical Programming, Data Management and Medical Affairs
  • Strong knowledge of tools for collecting and managing clinical and operational data such as SAS, EDC (RAVE) and CTMS.
  • Strong knowledge of content management tools including Veeva Vault
  • Good problem solving, technical writing and verbal communication skills
  • Ability to effectively manage multiple priorities with a sense of urgency
  • Attention to detail and accuracy of work
  • Strong knowledge of SDLC methodologies and CFR Part 11 compliance
  • Strong track record of project management, stakeholder management, budget management and collaboration skills
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.