Vice President Regulatory Affairs Quality Assurance

3 weeks ago


Princeton NJ, United States Afton Consulting Group Full time

Vice President of Regulatory Affairs & Quality Assurance

Are you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move.

The Role:

The Vice President of Regulatory Affairs & Quality Assurance is a strategic position that reports directly to the CFO/COO, with a dotted line to the CEO. You'll play a vital role in driving success by:

  • Championing Regulatory Affairs: Serve as the organization's regulatory expert, developing strategies to expedite the approval of filings and submissions (IND, NDA, BLA, etc.). Maintain awareness of current FDA/European/ICH guidelines.
  • Ensuring Uncompromising Quality: Lead and develop the quality assurance function, implementing standards and audits to guarantee product quality and compliance. Oversee the pharmacovigilance function.
  • Building Collaborative Relationships: Liaise with internal teams, external partners, and regulatory agencies to flawlessly execute the organization's regulatory vision.

Qualifications:

  • Bachelor's degree (Master's or RAPS certification preferred).
  • 10-15+ years of pharmaceutical/biotech QA/RA experience (GCP & CMC).
  • 5+ years in a QA/RA leadership position.
  • Deep knowledge of FDA/ICH/GMP regulations and expertise with BLA, IND & NDA submissions.
  • Strong business acumen and proven budget management skills.

Why You Should Apply:

  • High-Impact Role: Play a crucial part in shaping a forward-thinking organization. Your expertise will directly influence product success and company growth.
  • Strong Leadership Collaboration: Work closely with a dedicated top-level team committed to quality and innovation.
  • Impact: Influence the trajectory of innovative products that improve the lives of patients.
  • Executive Position: Collaborate with the C-suite to align company-wide strategies with regulatory and quality goals.
  • High Growth Potential: Help propel the company towards greater success as you develop and execute your vision.
  • Competitive Compensation: Enjoy an attractive salary and benefits package commensurate with your experience and skills.
  • Confidential Application Process: Your candidacy will remain discreet throughout the recruitment process.

If you thrive on regulatory challenges and are ready to lead from a position of authority and influence, we urge you to apply

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