Clinical Research Staffing stock photo

Vice President of Regulatory Affairs

Vice President of Regulatory Affairs oversees all facets of a company’s Regulatory Affairs, providing oversight for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities. In smaller companies this position may be combined to form a Vice President of Regulatory Affairs and Quality.

Contribution to Business Success

A strong Vice President of Regulatory Affairs can make a significant contribution to a company’s long-term financial success. The VP should be able to think strategically about the development pipeline for the company and assess which products are most likely to move through the regulatory process efficiently. The VP should be able to develop a tight timeline and coordinate the activities of all departments towards achieving a high-quality (defined as first time acceptance) and on-time submission. The VP should know regulatory road maps, such as for orphan diseases, which will speed up the clinical trial cycle, the regulatory process and garner more government resources. These things save the company significant money, not usually realized until the end of the regulatory approval process.

Contact us today to find a Vice President of Regulatory Affairs who will contribute to your company’s financial success

Major Achievements (examples)

  • Drafted, submitted and obtained acceptance of IND.
  • First-time, on-time submission and acceptance of NDA, BLA, PMA, IDE or similar regulatory documents.
  • Obtained orphan drug status granting increased engagement with FDA on drug development activities, exemption from all future product-specific regulatory fees, the opportunity to apply for R&D funding, tax credits, an increased chance of priority review, and 7 years of orphan exclusivity at time of New Drug Application (NDA) approval.
  • Successfully received product approval from foreign regulatory agency.
  • Efforts resulted in the end of a FDA study hold.
  • Efforts resulted in the ending of a Consent Decree.
  • Successful regulatory approval of product labeling.

Potential Pitfalls

  • Missed internal or regulatory agency deadlines.
  • FDA requirements not anticipated.
  • Not meeting regulatory requirements. Examples include early release of data, failure to insure patient confidentiality, incomplete regulatory submissions and failure to understand the different requirements made by each regulatory body (FDA, EMA, PDMA, etc..).
  • Poor ethical decisions.
  • Studies being put on clinical hold and FDA having a significant amount of follow up questions, which will require additional time, money and resources to answer.
  • Turnover of staff on the regulatory team is worse than the rest of the company.
  • Not building strong working relationships with the FDA, IRB and contributors to regulatory submissions (IND, NDA, PMA, IDE, etc) such as the Chief Medical Officer, and heads of Quality, R&D or Biostatistics.

If your Vice President of Regulatory Affairs has hit more than one of these pitfalls it may be time for a confidential search.

Searches

MEIRxRS aims to provide three top-notch candidates in 21 business days. We vet candidates closely, interviewing them, checking with their peers and assessing each candidate for abilities to help you achieve your business objectives.

Strong candidates for a Vice President of Regulatory Affairs will not be trolling job boards looking for their next position. They will be too busy avoiding potential pitfalls above and contributing to their business’s success. Generally, they will be working diligently toward their deadlines. Your company may have to wait a few months until a strong VP finishes up a regulatory submission for the current employer, so it’s best to start the search process as early as possible. Your company may want to use a consultant until a replacement starts.

Confidential Searches

Your company may wish to conduct a confidential search through MEIRxRS for a number of reasons. One is to keep a faltering leader on the job until a replacement can be found. Second is that the candidate pools for such position may be small and your company may not wish for its competitors to know that you may be interviewing their employees.

Retained Searches

Retained searches are less expensive if you are committed to filling a position. A portion of the fee is paid up front, a second payment is due during the interview stage and the final payment is due after the candidate starts work. Your retained search gets first priority over contingency searches.

Contingency Searches

Companies sometimes engage multiple agencies concurrently in an effort to speed the search up. Unfortunately, this results in a barrage of agencies submitting poor-quality resumes in an effort to get their candidates in first (and earn the fee) in case they are good. Resumes may be submitted even if the candidate hasn’t been interviewed or told that their resume is being submitted to your company. Recruiters place multiple calls and emails to get the resume in first, diverting attention of hiring managers from their other responsibilities. All this undermines our goal of providing top-notch candidates for our clients. Because of this MEIRxRS will not conduct a contingency search if other agencies are working the search at the same time.

Requirements for a Vice President of Regulatory Affairs

Requirements usually include a Master in Regulatory Affairs and/or a Regulatory Affairs Professional Society (RAPS) certification plus 5 or more years of experience. Preclinical and clinical-stage companies need previous experience submitting INDs and NDAs (respectively). Experience in a specific therapeutic area is generally not required.

Tasks

  • Direct submissions, such as INDs and NDAs, to the Food and Drug Administration as well as foreign regulatory authorities.
  • Coordinate the regulatory contributions of team members including biostatistics, clinical operations, quality, and medical affairs.
  • Insure regulatory compliance across all aspects of the company.
  • Represent organization at regulatory meetings.
  • Prepare, submit and disseminate reports internally and to regulatory bodies.

Suggested Readings

Candidates

If you would like to be confidentially contacted when we have a relevant Vice President of Regulatory Affairs search please contact a talent manager today.

Begin the Search for a Vice President of Regulatory Affairs

Contact us today to schedule a time and discuss your company’s specific needs.

Fill out my online form.
Logos of our membershipsmore Logos of our memberships