Manager, Regional Regulatory Strategist

  • Represent United States (US) Regulatory Affairs
  • Provide strategic expertise as a member of the Global Regulatory Strategic Team (GRST)
  • Lead and implement US regulatory strategies in agreement with key stakeholders for assigned projects and in line with the commercial goals
  • Be accountable for timely submissions and approvals with commercially attractive labelling
  • Be accountable for ensuring optimal regulatory interactions with US FDA in relation to the assigned projects
  • Projects assigned can be in development and/or at post-authorization stage

  • Accountable for ensuring US contribution to global regulatory strategies and implementation plans for assigned projects
  • Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities
  • Partners with project teams and other customer groups (e.g. Clinical Study Teams; Post-Authorization Study Teams; Program Management; Worldwide Safety) to ensure required regulatory contributions meet business needs and are provided to agreed time and quality standards
  • Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management and any risks (from emerging data, changing internal objectives or external threats) mitigated
  • Ensures an aligned US regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions are championed and communicated
  • Ensures business compliance and implementation of and adherence to Regulatory standards
  • Maintains internal regulatory databases, tracking and document management systems as appropriate
  • Supports query and commitment management in collaboration relevant stakeholders
  • Develops and maintains, directly or indirectly, constructive working relationship with FDA contacts
  • Engages in appropriate activities in order to influence the US regulatory environment through Regulatory colleagues, Agency contacts and/or Trade Associations as appropriate

  • BS degree required plus 5+years of experience.
  • Minimum 5 years of US Regulatory Affairs experience
  • Experience in regulatory management of a US IND, responses to FDA requests for information/FDA comments, and representing Regulatory Affairs in cross-functional teams
  • Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines
  • Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management


Not applicable


Limited travel may be required in the future

Other Job Details:

Last Date to Apply for Job: 09/19/2021
Additional Location Information: USA - PA - Collegeville; United States - New York - New York City; United States - New York - Pearl River; United States - Remote
No Relocation Offered

Eligible for Employee Referral Bonus


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Regulatory Affairs