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.

• 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.

• Occasional travel up to 30% (global).