Regulatory Affairs Specialist

SUMMARY:
Our client in the FMCG industry is looking for an experienced Regulatory Affairs Specialist.

POSITION INFO:

Minimum requirements for Skills/Education/Experience:

EDUCATION:

• Matric essential

• Bachelors degree in biology / chemistry / pharmacy / nutrition / food science or related fields are preferred.

EXPERIENCE:

• Previous industry or related work experience strongly preferred

• Knowledge of South Africa, Botswana, and other Southern Africa regulations for food and cosmetics essential • knowledge of EU food and cosmetic regulations preferred.

SKILLS: 

• Clear and concise oral and written communication skills in English

• Fluency in a European language is preferred

• Knowledge of Microsoft Office software (Outlook, Excel, Word)

• Excellent organizational skills and ability to multitask and adapt to flexible environments

• Detail-oriented approach • Ability to adapt in a fast-paced setting with evolving goals and objectives • Autonomous approach

• Ability to interact with professional industry and government level contacts with confidence

• Ability to systematically analyse problems and propose thorough, efficient, and creative solutions

• Team oriented with good people skills 

Job Responsibilities:

• Demonstrates strong knowledge of relevant national product compliance regulations, including but not limited to CAM regulation, health claims, labeling, formulation, and product registration/notification and veterinary certificate requirements for countries of responsibility;

• Provides a regulatory review of new concept formulas to determine ingredient acceptability, product classification, and potential sales restrictions in countries of responsibility;

• Together with the Regulatory Support Administrators, develop new and revised printed components through defined workflows in the company database, ensuring their regulatory compliance prior to printing

• Obtains product registrations, notifications, and certifications by requesting, preparing, and submitting to government authorities and third-parties data from manufacturers and various company sources;

• Responds to inquiries from government authorities by requesting, preparing, and submitting technical and non-technical data from manufacturers and various company sources;

• Maintains self-compliance and renews existing registrations, notifications, and certifications for countries of responsibility;

• Drives changes for raw materials, formulas, printed components, and SKU’s through the company database, ensuring that all data are up-to-date;

• Keeps abreast of general and product regulatory compliance developments in countries of responsibility. Communicates those issues in a timely fashion to supervisor and impacted functions;

• Carries out all responsibilities in an honest, ethical and professional manner;

• Supervisory responsibility over projects is required. Training of peers may be a requirement.

• Tracks and manages monthly costs, by product, incurred with in-country attorneys, consultants, and third-party agencies. Liaises with in-country Finance to ensure that accruals match the invoices;

• Effectively communicate both written and verbal, and in-person with regulators, relevant authorities, consultants, manufacturers, and other departments on a daily basis with regard to all aspects of the product lifecycle. Understands when to involve Supervisor in these communications

• Reports project statuses to the direct supervisor on a weekly basis, through meetings established by the department head, or through reporting, as necessary.

• Interact with competent Regulatory authorities, consultants and attorneys, Research and Development, Quality Assurance, Quality Control, Marketing, Country Management, Manufacturing, Procurement, Packaging, Supply Chain Management, Creative Services, Global Regulatory Affairs, Government Affairs, Scientific Affairs, Legal, Nutrition Advisory Board, Member relations as well as local staff

• Keeps abreast of general and product regulatory compliance developments in countries of responsibility. Communicates those issues in a timely fashion to direct supervisor;

• Communicates to direct supervisor any potential changes that could improve efficiencies within and outside of the Specialist role

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