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Vice President Regulatory Affairs Quality Assurance - Princeton, United States - Afton Consulting Group
2 weeks ago
Description
Vice President of Regulatory Affairs & Quality AssuranceAre 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.
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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