Vice President, Regulatory Affairs

Massachusetts
4954
Our client is a biotechnology company specializing in synthetic biology. They have asked us to assist them in a search for a Vice President, Regulatory Affairs.  

Major tasks and responsibilities include:
  • Develops and implements strategies to facilitate the progress of potential therapeutics into clinical trials through registration.
  • Leads the regulatory affairs team by providing guidance, coaching, and mentoring to internal regulatory affairs staff as well as any contractors, consultants, and vendors.
  • Serves as a regulatory representative on selected project teams, including authoring documents as needed.
  • Serves as a regulatory liaison with partners, the FDA, and other regulatory agencies.
  • Reviews technical reports and summary documents for adherence to regulatory guidelines, strategies, and commitments.
  • Recommends regulatory policies to assure adherence to FDA and EMA requirements.
  • Keeps abreast of all pertinent laws, regulations and guidance, and provides insight on current regulations and guidance documents relevant to product development projects.
  • Provides subsequent recommendations for regional regulatory strategies and implementation activities.
  • Works with quality assurance teams to provide regulatory expertise and policy support for good pharmaceutical practices.
  • Contributes to the modification, development, and implementation of company practices and policies related to regulatory affairs.
  • Ensures appropriate scheduling and tracking of operational activities relating to the regulatory department.
 
We seek candidates with the following qualifications:
  • A Bachelor’s degree or Master’s degree in a life science or relevant discipline is required.
  • Must have a minimum of 10+ years of broad regulatory experience including a focus on regulatory strategy.
  • The demonstrated ability to interface with cross-functional teams as well as regulatory agencies is required.
  • Requires experience with Phase I through product registration in a global setting.
  • Must have excellent writing and interpretive skills.
  • Experience with CMC regulations is preferred.
  • Proficiency in strategizing, planning, monitoring and problem solving is required.
  • Must be team oriented with excellent communication and interpersonal skills, and the demonstrated ability to manage indirectly.
  • Strong facilitation, organizational, analytical and time management skills are required.
  • Must have the ability to apply knowledge to new situations and to dig into new areas of science and medicine.
  • The ability to articulate complex and broad concepts and translate them into plans for action and constructive improvement is required.
 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.
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