Sr. Director of Regulatory Affairs

Hauppauge, NY

Posted: 10/04/2018 Industry: Laboratory - Food & Beverage Job Number: 435.18TS Pay Rate: 200,000

Sr. Director of Regulatory Affairs

As a senior strategic leadership role, the successful candidate will be expected to build high performing relationships across the Global organization, as well as the other Regulatory Affairs teams located in the U.S., Canada, and the United Kingdom to facilitate global growth.  Responsibilities include, but are not limited to:

  • Establish a new Global Regulatory Strategy group for the company, focused on enabling sales and profit growth through development of innovative regulatory solutions across all three Franchise groups
  • In market (US) compliance of products, packaging, claims and communications (total product offering)
  • Manage the activities of the Global Regulatory Strategy and US Regulatory Affairs teams
  • Partner with legal and Nutrition/Scientific Affairs to manage litigation and provide depositions as required
  • Represent the company externally as required
  • Review and approve regulatory strategies for product development and submissions that are formulated by the regulatory teams, ensuring risk assessments are in place and aligned across the business to minimize business risk
  • Direct, plan, and review the work of all team members, maximizing the value they bring to the organization
  • Provide direction, coaching and feedback to regulatory affairs staff responsible for the review and approval of promotional materials and labeling for products
  • Serve as a resource for disputes that might arise due to any of these regulatory activities
  • Provide direction to the regulatory affairs staff responsible for the regulatory submissions teams
  • Senior regulatory review of new product labeling, and oversight of labeling systems
  • Management of process for review and approval of advertising and promotion for the Company’s products
  • Hire appropriate staff and conduct training and review of their activities
  • Prepare and maintain annual budgets and long-range planning for Regulatory Affairs
  • Develop and implement regulatory policy consistent with corporate policy and FDA regulatory requirements
  • Develop strategic direction to the leaders of the regulatory teams responsible for communications and meetings with FDA
  • Coordinate regulatory activities with internal stakeholders globally

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Tamra Sanders at tsanders@cps4jobs.com.

JO:  435.18TS
#LI-TS1

 

Requirements:

  • Functional experience: Minimum of (10+) years of progressive direct management / leadership of a regulatory affairs organization
  • Industry experience: Solid understanding of the consumer healthcare / nutraceutical industry landscape and market trends
  • Leadership experience: Demonstrated leadership skills in leading a dynamic, high-performing team by setting and meeting goals and motivating cross-functional teams
  • Operational experience: Proven ability to build regulatory processes and systems.  Quality experience / background is a plus
  • Technical expertise: Strong track record and technically savvy in the Regulatory Affairs function, able to provide expertise and guidance on product submissions with global health authorities
  • Stakeholder experience: Experience working with global, cross-functional teams desired
  • Bachelor’s degree required; Advanced degree desirable

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Tamra Sanders at tsanders@cps4jobs.com.

JO:  435.18TS

#LI-TS1

Tamra Sanders
Sr. Technical Recruiter

Tamra Sanders

Sr. Technical Recruiter/Food and Beverage 

Specialties: All Food and Beverage Industries positions including: Product Development, Research, Sensory, Nutrition, Culinary, Flavorist, Applications, Analytical, Regulatory, Quality Assurance, Technical Service, Ingredients, and B2B Ingredient Sales.

Experience: I have 10+ years of experience in recruiting and the last 5 years in Food and Beverage. I partner with small and big Food and Beverage companies (CPG and Ingredient) throughout the US helping them secure GREAT employees.

 

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