Company Confidential

POSITION:                           Director, Regulatory Affairs

Location: east coast

SUMMARY:  Accountable for policies and procedures insuring company compliance with all applicable global regulatory/compliance/safety laws and regulations. 

ESSENTIAL DUTIES and RESPONSIBILITIES include the following.  Other duties may be assigned.

1. Leads the Regulatory function and larger Company in maintaining active compliance within an ever-changing regulatory environment across multiple sites.

1. Anticipates changes to the Regulatory and business landscape and provides direction to the Company in preparing for and addressing these changes.

1. Favorably represents the Company and its interests to shareholders, regulatory bodies and customers.

1. Is responsible for the training, guidance, development, and coaching of all direct reports of the Regulatory department.

1. Researches and interprets regulatory data including, but not limited to changing regulations, advisory panel output, position statements and scientific studies and presents summaries and suggested courses of action to Management.

1. Reviews regulatory/compliance/safety laws and regulations which govern and impact our company operations and compares them to current practices, (i.e., GMP). Insures our company compliance through standard development, implementation and audit systems.

1. Institutes processes, procedures and training to support corporate geographic, market, product and industry expansion which may involve
   1. Import/export requirements, duties, taxes and shipping requirements
   2. Product approval processes in various geographic locations
   3. Regulations, laws and industry standards for various industry segments (Food, Cosmetic, pharmaceutical, etc.)
   4. Substantiation of product claims, label regulations, patent process knowledge and experience
   5. Confidentiality agreements and customer processes

1. Ensures success, timely completion and cost containment of regulatory projects which may involve subcontractors and consultants.

1. Monitors regulatory status of our existing materials and capturing regulatory status for our emerging ingredients on a global basis by managing and filing all necessary petitions and communications with relevant regulatory bodies: for example, in the case of the US GRAS and or Self-Affirmation Submissions.

1. Regulatory aspects of product label approval, to include but not limited to
   • ingredient listing
   • country of origin
   • allergen review

1.  Responds to routine customer inquiries and follows up as appropriate.

1. Participates in symposia, industry and governmental groups and conferences.

1. Conducts regular internal auditing of all aspects of the compliance and regulatory areas to ensure no gaps identified.

1. Responsible for the dissemination of critical regulatory information throughout the company through training, updates, etc.

1. Displays and enforces the cultural values of the company.

1.   Other duties as assigned.

EDUCATION and/or EXPERIENCE:

Minimum 4-year, BS level degree, prefer advanced degree in a legal discipline,  Food Science,  or Chemistry.  A minimum of 5+ years professional experience in food or related industry in a Regulatory capacity; 8 years of experience preferred.  Management experience is required. 

REGULATORY EXPERIENCE:  Abilityto effectively communicate with appropriate governmental (and non-governmental) regulatory agencies such as FDA, FEMA as well as customers, internal contacts, and other regulatory personnel.

SUPERVISORY RESPONSIBILITIES:

Directly supervises the positions of Regulatory Specialist.  Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Supervisory responsibilities include, but are not limited to, hiring and training employees, planning, assigning and directing work, appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems.  Uses own initiative and exercises independent judgment.