Associate Manager, Regulatory Intelligence

The Associate Manager of Regulatory Intelligence supports and coordinates Regulatory Intelligence (Reg Intel) proactive global monitoring and surveillance activities of the full drug development lifecycle from preclinical through commercialization. This position may have limited exposure in supporting initial draft comments on key regulatory documents and requirements (e.g. regulations, guidance, directives, etc) to global Health Authorities.

In this role, a typical day will have the following responsibilities:

We are seeking an Associate Manager of Reg Intel who can lead the collection, build at, maintain and distribute regulatory newsletter content to the organization. He/She also owns the content of and updates to the Regulatory Intelligence SharePoint and RON sites (e.g. tracking industry meetings and events).
In addition, we need this role to support internal partners with the collection and distribution of requested regulatory intelligence queries or information on less complex topics. This includes drafting summary of revisions for updated guidance and regulations documents. The role also performs quality check of global regulatory requirements and documents for appropriate categorization, metadata, redundancies, errors, and documents that are out of scope.
The Associate Manager of Reg Intel contributes to the development of regulatory intelligence reports or results as it relates to project strategies for less complex topics. He/She shares/inputs data into systems or tools to enable effective knowledge management of country-level operational intelligence data. He/She also supports senior team members on sophisticated queries, initiatives and deliverables. This activity includes providing entry and tracking of impact assessment decisions and action as evaluated and determined by cross-functional review team, including team decisions and actions.
Additionally, the Associate Manager Reg Intel may support distribution of key regulatory information to targeted departments and partners. He/She may conduct initial analysis of commenting opportunities. He/She may assist with drafting of comments for submission to industry organizations, Health Authorities and other partners with oversight by more senior Reg Intel team member. He/She assists in developing and refining regulatory intelligence processes and procedures to build efficiencies. This role also tracks minutes from Reg Intel led meetings, and coordinates review meetings and/or lunch-n-learn sessions.This role might be for you if you have:

• Bachelors Degree required.
• Minimum of 2-4 years proven experience in the biotech/pharmaceutical industry. Prior experience in Reg Intel is a plus.
• Good understanding of the drug development and commercialization process. Basic knowledge in the monitoring and sourcing of regulatory requirements' information in pharmaceutical industry.
• Experience with Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc.)
• Highly organized and able to work independently to meet deliverables on time and on target.
• Excellent communicator, both written and oral, in a multi-disciplinary team environment.

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