Regulatory Affairs Specialist

Reporting to the Head of Process & Application, the role of the Regulatory Affairs Specialist is to 1) assure compliance of product formulas, labels, and communications, 2) contribute to and advise Innovation & Renovation projects, and 3) understand the impact of regulatory proposals and changes and be of guidance to the company and its brands as requested. The role is interacting across departments. 

Key Accountabilities

Regulatory Foundation:

• Foundation: by developing and maintaining internal networks (e.g., QA Managers, Process Support, R&D) and external networks (e.g. International Regulatory Bodies, Certification Bodies) to effectively accomplish work
• Engaging with external Regulatory experts and participating in regulatory committees to keep abreast with the global regulatory framework.
• Identifying potential regulatory issues and implementing a Regulatory newsletter to keep the organisation informed.
• By contributing to the maintenance of FCP systems (Ingredient permissibility database, Product compliance database etc.) and identifying opportunities for improvements to them.
• Provide internal training to develop fundamental knowledge of regulations.

Regulatory Compliance:

• Providing regulatory perspective for new and renovated products by identifying and resolving regulatory hurdles as early as possible in the development process - "compliance by design"
• By supporting speed to market through contribution to scientific and regulatory dossiers and registrations required by regulation or company policy.
• Manage the registration process required by regulatory bodies in various countries (preparation of dossiers, translations, mock-up samples, etc.)
• By applying knowledge and experience of country regulations and Foster Clark’s policies to review and assure flawless compliance of ingredients, formulations, labelling information claims and other sensitive communications.

Others

• Support external audits and certifications to ensure company/product certifications are maintained.
• Contribute to the internal auditing process.

Ideal Candidate Profile

Education

• Requires BS/BA, preferably in nutrition and/or food science; MS/MA preferred. BS/BA in another field with min. 3 years relevant regulatory experience in the food industry could be considered.

Experience

• 3+ years’ experience in the industry (FMCG or Pharma)
• 2+ years’ experience mainly in regulatory affairs, regulatory compliance, nutrition or product development.

Technical Skills

• Excellent Knowledge and Understanding of EU, Codex, FDA and USDA label regulations and documentation requirements.
• Strong understanding on the application of Framework Requirements to ensure product & label compliance.
• Sound knowledge about food products and composition.
• Knowledge of and experience with ISO 9001, GFSI Quality Systems such as BRC, FSSC 22000, ISO 9000.

Competencies

• Analytical thinking and problem solving.
• Action orientated.
• Building strategic partnerships.
• Influencing and impact, including conflict management.
• Consulting and advising.
• Monitoring and measuring.