Assoc Mgr Regulatory Intelligence

Location
Basking Ridge, New Jersey
Posted
Jun 14, 2022
Ref
REGEA0026R9919
Required Education
Bachelors Degree
Position Type
Full time

Associate Mgr. Regulatory Intelligence role entails proactive monitoring and surveillance of changes in the global regulatory landscape focused on the drug development lifecycle starting from preclinical through commercialization. Experience in CMC a plus.

In this role, a typical day might include the following:

  • Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders
  • Monitor and analyze global regulatory intelligence sources for the most current changes and information in the drug development space
  • Assess regulatory intelligence information for relevance and impact to company’s internal processes, drug development projects and/or regulatory strategies
  • Identify business critical aspects and communicate effectively to internal stakeholders
  • Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information.
  • Provide regulatory intelligence in support of a range of operational study design and operational planning activities as well as CMC queries and requests.
  • Produce regulatory intelligence reports or deliverables as it relates to project or process strategies
  • Collaborate with cross-functional team from preclinical to commercial to identify and assess key regulatory requirements, regulations, guidance’s, and information 
  • Synthesize information from global requirements database as well as interaction with local country experts as needed
  • Share/Input data into systems or tools to enable effective knowledge management of country level operational intelligence data. 
  • Conduct the initial analysis of commenting opportunities and assist with drafting of comments for submission to industry organizations, Health Authorities and other stakeholders
  • Facilitate regulatory intelligence review meetings and/or lunch-n-learn sessions
  • Develop and refine regulatory intelligence processes and procedures to build efficiencies
  • Assist in the collection and maintenance of regulatory intelligence newsletter content and distribution to organization
  • Assist Director of Regulatory Intelligence in other projects or activities as needed

This role might be for you if:

  • Knowledge of applicable regulatory requirements and guidelines relevant to drug development
  • Experience working with cross functional stakeholders at varying levels within the organization
  • Excellent Communication skills (written, oral, facilitation of meetings, etc.)
  • Proactive; Tactical and Operational decision making skills; Can prioritize and manage own work
  • Bachelor’s Degree
  • Advanced Degree a plus
  • 3-5 years in Industry

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.