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Manager, Global Regulatory Affairs - Strategy

Reference Number: 3192
Location: NJ

Our client is a global pharmaceutical company addressing unmet medical needs.  They have asked us to assist them in their search for a Manager, Global Regulatory Affairs – Strategy.

Major tasks and responsibilities will include:

  • Represents GRS on project teams and communicates strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model.
  • Researches, develops and implements regulatory strategies to facilitate global approval of new medicinal products.
  • Plans, executes and assesses the product life cycle management activities and strategies - all with a global focus.
  • Leads interactions with the US Food and Drug Administration.
  • Provides advice on US regulatory clinical trial and marketing authorization requirements to the Regulatory Sub-team and the International Project Team (IPT).
  • In addition, the candidate will have ownership of the preparation and submission of documents to Regulatory Authorities (Meeting Requests, Annual Reports, and Protocol Amendments etc.).
  • Organizes resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.
  • Develops and implements regulatory strategy for the assigned projects.
  • Leads issue resolution of regulatory risks by identifying, escalating and monitoring issues.
  • Contributes to the planning, execution, and assessment of product life cycle management activities and strategies.
  • Contributes to, and implements strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities.
  • Contributes to the department-wide work-stream/initiatives, as assigned.

We seek candidates with the following qualifications:

  • 4 years of pharmaceutical industry experience, including 2 years' experience of new drug regulated product strategy and submissions.
  • This person must assume accountability for a project goal/objective.
  • This person must distill and succinctly communicate strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model.
  • Candidate must be adept at tailoring and translating key messages based on Stakeholder need and issue at hand.
  • Candidate must be adept at leading team discussion to resolve and reach agreement on project issues.
  • Candidate should be comfortable working independently to create Health Authority correspondence, and attending specific project team meetings (such as Clinical Study Team Meetings) as the Regulatory Affairs Representative and providing guidance to project teams on all areas of pharmaceutical drug development.
  • A working knowledge of relevant drug laws, regulations and guidance's/guidelines is highly desirable.
  • Global experience is a plus.
  • Candidate will work with autonomy, however must be comfortable escalating strategic or operational issues to the hiring manager as appropriate.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3192. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.