Vice President Regulatory Affairs

2 weeks ago


New York, United States CSG Talent Full time
Vice President of Regulatory Affairs

My client is a Top 10 Pharma looking for a new VP Regulatory affairs. They have been a secure fortune 500 company for many years and are expanding their team across the US and globally. With over 2000 employees they have a track record of leading the industry and expanding their clinical settings.

Overview

As the Vice President of Regulatory Affairs, you will play a pivotal role in our organisation by effectively managing regulatory strategies and compliance efforts. Your responsibilities include liaising with regulatory agencies, leading submissions, and ensuring timely approvals. You'll collaborate with cross-functional teams to achieve regulatory milestones and maintain compliance with global regulations.

Responsibilities

  1. Regulatory Strategy and Leadership:

    • Develop and execute regulatory strategies aligned with organisational goals.
    • Serve as a key contact for regulatory agencies and coordinate meetings.
    • Lead the preparation of regulatory submissions.
  2. Global Project Support:

    • Participate in project team meetings and provide regulatory guidance.
    • Collaborate with various disciplines to gather information for filings.
  3. Continuing Education:

    • Stay current with regulations and attend relevant conferences.
    • Research answers to regulatory affairs questions.

Qualifications

  • Education:

    • Bachelor's degree required.
    • Advanced degree (e.g., Masters, PharmD, Ph.D., MD) preferred
  • Experience:

    • Minimum 10 years in the pharmaceutical industry.
    • At least 7 years in regulatory affairs.
    • Familiarity with IND and NDA/BLA processes.
  • Competencies:

    • Strong communication skills (oral and written).
    • Ability to work in a team environment.
    • Detail-oriented and proactive.

Travel

  • Occasional travel up to 30% (global).


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