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 a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization’s GxP framework.
In this role, a typical day might include :
Project Management and leadership in the delivery of regulatory intelligence research services and information
Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders
Managing more complex intelligence query requests from internal stakeholders
Serving as the functional lead on cross-functional organizational level projects or initiatives in supporting of GxP compliance or requirements
This role might be for you if can :
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. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input into feasibility.
To be considered for this opportunity, you must have the following :
Advanced life science degree or related field
Minimum of 7 years experience in the biotech / pharmaceutical industry with a strong focus in Regulatory Intelligence
Good understanding of the drug development and commercialization process, with a focus on clinical development and trial execution
Experienced in understanding and interpreting regulatory guidelines and documents
Ability to research, analyze and extrapolate critical regulatory information, with a focus on clinical requirements and recommendations
Please note, this role requires you to work 3 days onsite weekly out of our New York or New Jersey offices. If you are not local and qualify, we can offer a relocation package!
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