Dir., Regulatory Affairs

11 - 15 years experience  •  Retail & Consumer Goods

Salary depends on experience
Posted on 06/18/18
Ronkonkoma, NY
11 - 15 years experience
Retail & Consumer Goods
Salary depends on experience
Posted on 06/18/18

Job Description 

As part of the Company’s focused, growth-driven strategy and plan to expand into several new product areas and global markets, the Company is seeking a seasoned Director, Regulatory Affairs. This is an exciting opportunity for the Director to establish a new Global Regulatory Strategy group for the Nature’s Bounty Co., developing and implement global regulatory strategies not just supporting but enabling growth. In addition, the role will hold responsibility for US 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 US, 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 Nature’s Bounty Co., 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 Nature’s Bounty Co. 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


Qualifications 

  • 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.
  • Bachelordegreerequired; Advanced degree desirable.
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