A Florida, U.S.-based aggressive bioresearch company with core competency in feedstuffs and foodstuffs and plans to develop into other areas is seeking a regulatory affairs manager.

PRIMARY FUNCTION

  • Develop and lead the implementation of global regulatory strategies for products in the areas of animal feed, human food, transportation fuels and agricultural products.
  • Provide regulatory project management to obtain approvals for products in selected countries.
  • Recommend operational strategies to support regulatory compliance in selected countries.

MAJOR RESPONSIBILITIES

  • Lead and manage regulatory contribution to product and technology teams providing feasibility assessments for due diligence.
  • Lead the development and implementation of global regulatory strategies and submissions for all products.
  • Guide substantiation for regulatory product classification.
  • Interface with regulatory authorities on substantiation requirements, pathway assessment and issues related to success of regulatory submissions.
  • Leverage best practices and ensure compliance necessary to support regulatory approvals.
  • Accountable for understanding, communicating, and assuring compliance with relevant global regulations.
  • Support sales and deployment activities worldwide as required.

MANAGEMENT RESPONSIBILITIES 

  • Provide team guidance in development of strategies to support regulatory approvals.
  • Manage internal and external contribution to regulatory plans.

QUALIFICATIONS

  • Prior international regulatory experience in animal feed and/or food industry; Asian experience preferred.
  • MS in nutrition, chemical or biological science is required.
  • Demonstrated ability to work productively and collaboratively with regulatory agencies, external regulatory consultants and internal stakeholders (scientist, marketing, quality assurance, product development) to develop, implement and communicate global regulatory strategies.
  • Highly effective verbal communication skills.
  • Demonstrated ability to travel and work remotely in self-motivated fashion is required.

A competitive remuneration package will be offered to the selected person.

Qualified, interested candidates can send resumes in strict confidence to JCB Consulting jc.brown2@ntlworld.com with “Regulatory Affairs” in the subject line.