Director of Regulatory Affairs
GENERAL PURPOSE OF JOB
The Director of Regulatory Affairs will serve as the primary company resource for regulatory and compliance to ensure that our products meet all applicable laws and regulations, including those laws specifically enforced by the FDA, EFSA and other international regulatory authorities; create and institute appropriate policies, practices and procedures to achieve and ensure such compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Oversee all regulatory and compliance matters to ensure appropriate practices, both domestically and internationally, for a diverse corporation with significant growth opportunities.
- Oversee the legal aspects of all FDA, EFSA and other international regulatory authority related matters.
- Interface regularly with the executive team, external/internal clients, and business partners.
- Keep senior management informed by determining governmental affairs needs, and producing compliance bulletins on legislative and regulatory changes.
- Ensure all products, labels and advertising materials comply with all applicable laws and regulations in the relevant domestic and international markets.
- Develop, implement, and manage a strategic compliance plan in support of business objectives, including the budgeting for and managing of external regulatory consultants.
- Provide practical, pragmatic guidance and recommendations on new product formulations, labels, and usage claims to innovation teams to assure compliance with applicable domestic and international laws and regulations;
- Represent the company and participate in industry-related regulatory committees on its behalf;
- Support international and contract manufacturing customers with documentation needed to register products in local markets and/or obtain listings with key customers
Knowledge, Skills and Abilities:
- Knowledge of the position
- track record providing regulatory guidance, legal analysis and leadership in or to the functional food or dietary and nutritional supplement industry
- depth knowledge of FDA regulations applicable to functional foods and dietary supplements; and working knowledge of applicable EU or other similar international regulations
- and consultative team player who possesses an ability to work well both independently and in a team environment
- a “roll-up-the-shirt-sleeves” attitude
- thriving in a challenging, fast-paced environment
- Skills of the position
- issue identification and problem-solving skills with excellent organizational skills and attention to detail;
- manage and prioritize numerous requests from across the business to effectively support operations and company objectives within a changing, fast-paced environment;
- interpersonal and communication skills, and an ability to convey complex legal principles clearly and concisely to a variety of audiences and constituencies;
- Abilities for the position
- and gravitas with the ability to build relationships across the entire organization, including the business and product teams and other legal team members;
- business acumen with the ability to recognize the business consequences of legal advice
- and a team-oriented approach, and capable of building strong, strategic relationships while maintaining his/her own independence.
- business partner who brings a practical, commercial focus to the dispensation of regulatory advice, and is comfortable assuming a proportionate amount of risk in advancing the Company’s business.
- Degree or equivalent experience: BA/BS, or MS degree in science is strongly preferred
- Extensive experience at a major company, pertaining to the manufacture and sale of functional foods or dietary and nutritional supplements for domestic and international markets
- Years of experience:7+ years’ regulatory experience in or supporting the functional food or dietary and nutrition supplement industry
- Experience developing and managing others required