Senior Manager Regulatory Intelligence

Basking Ridge, NJ, United States
May 20, 2021
Required Education
Bachelors Degree
Position Type
Full time
This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape, focused on drug development lifecycle starting from preclinical through commercialization. This position will also serve as lead contact in support of requests and cross-functional requests and initiatives from assigned departments or functions within the organization's GxP framework.

In this role, a typical day might include the following:
  • Collaborate on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with senior leaders
  • Functional lead on cross-functional organisational level projects or initiatives in supporting of GxP compliance or requirements
  • Monitor the external regulatory environment, including guidances and regulations from regulatory authorities, trade organisations, working groups, and relevant industry leaders
  • Analyse global regulatory intelligence sources for the most current changes and information in the clinical development space
  • Identify business critical aspects and communicate effectively to internal team members
  • Provide regulatory intelligence to assist with a range of operational study design and operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input into feasibility.
  • Produce regulatory intelligence reports or deliverables as it relates to project or process strategies
  • Synthesise information from global requirements' database as well as interaction with local country specialists as needed
  • Conduct the initial analysis of commenting opportunities and assist with drafting of comments for submission to industry organisations, Health Authorities, etc
This role may be for you if:

We require a Bachelors Degree, with a minimum of 8+ years proven experience in the biotech/pharmaceutical industry. You must have a good understanding of the drug development and commercialisation process, with a focus on clinical development and trial execution. We are looking for experience in understanding and interpreting regulatory guidelines and documents. You should have an ability to research, analyse and extrapolate critical regulatory information. You will also be highly organised and able to work independently to meet deliverables on time and on target.
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.