Director, Business Solution Partner, Regulatory Affairs & GCP Quality

Location
Tarrytown, NY, United States
Posted
Sep 11, 2020
Ref
21466BR
Required Education
Bachelors Degree
Position Type
Full time
We are looking for a Business Solution Partner for Regulatory Affairs and GCP Quality. The primary objective of the role is to drive the strategy of solutions and capabilities for these functional areas, and translate these strategies into new solutions, technologies and/or services. Growth opportunities exist for cross competency (i.e., Solution Delivery/Operations) and/or cross domain responsibilities (i.e., Data Management, Regulatory, Safety and Medical Affairs). We are looking for a strong leader that can drive success in the functional area.

In this role a typical day might include:

Being a Strategic Partner
  • Driving strategy for Global Development Systems for RA and GCP Quality
  • Accountability for understanding the needs, priorities and challenges of the group to establish the strategy for delivering solutions and related service capabilities
  • Ongoing understanding of processes, plans, objectives, drivers, and issues, together with external policies and regulations to ensure compliance and effective service delivery
  • Ensuring that solutions are identified, implemented and utilized to ensure intended outcomes are realized
  • Accountability for communication with all impacted business partners
  • Partnering with vendors in keeping abreast of technology trends and applicability to business needs
  • Introducing new innovative solutions and technologies to the functional area(s)
Delivery Oversight
  • Oversight and steering of delivery of solutions related to RA and GCP Quality
  • Translating business needs into delivery strategies - solutions, technologies, and services
  • Delivering business cases and prioritizing across the portfolio
Operational Excellence
  • Ensuring value propositions of planned solutions are effectively captured, communicated and measured post-delivery
  • Management of resources, including supply and demand, to achieve desired outcomes
  • Accountability for the execution and governance of the group's solutions portfolio and budget
  • Preparing the budget, coordinating with GDS Leadership, functional area leadership, the Program Management Office and Finance as needed
This role may be for you if you have:
  • Knowledge of business processes and systems used for the function
  • Direct, hands-on experience implementing capabilities in Global Development domain, specifically in Regulatory Affairs and GCP Quality
  • Ability to identify the cross-functional process requirements for partners, as well as ability to drive alignment
  • Experience managing technology capability identification, selection and implementation in Regulatory Affairs and GCP Quality
  • Good problem solving, technical writing and verbal communication skills
  • Ability to effectively manage multiple priorities with attention to detail and accuracy of work

To be considered for this opportunity you must have aBS/BA Degree with 10+ years relevant experience or MS/MA/MBA degree and 8+ years relevant experience. Strong knowledge of SDLC methodologies and CFR Part 11 compliance. A strong track record of project management, partner management, budget management and collaboration skills

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.

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