Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job Summary : The Regulatory Affairs Specialist will provide support to the Director of Regulatory Affairs in relation to the Company's regulatory compliance efforts.

Job Expectations :

• Assist in managing regulatory affairs matters for the company
• Responsible for supporting registration / regulatory needs to maintain and further develop the regulatory capability of the Company
• Ensure compliance with regulatory requirements for Company's products
• Responsible for preparing and submitting regulatory documents, reviewing labels and other materials for compliance
• Updates internal SOPs / forms / work instructions and assists with internal training of associates regulatory and internal processes
• Keeping abreast of evolving regulations to support product development and commercialization.
• Collaborate with cross functional teams to ensure regulatory compliance
• Assist in preparing and submitting regulatory documents (product registration dossiers, technical files, labeling, and packing information, to in accordance with applicable regulations)
• Provide administrative support with the compilation and maintenance of product regulatory files, ensuring the accuracy and completeness of all required documentation
• Support regulatory assessments of product formulas, claims evidence, packaging, and leveling to ensure compliance with local and international regulations
• Assign in evaluating ingredient and formula evaluations
• Assist in development regulatory guidance documents for cross functional teams
• Perform other related duties as required and assigned

The duties and responsibilities described above may provide only a partial description of this position. This is not an exhaustive list of all aspects of the job. Other duties and responsibilities not outlined in this document may be added as necessary or desirable, with or without notice.

Knowledge, Skills and Abilities : Required :

Equipment Knowledge :

Experience Requirements :

Generally requires a minimum (7) seven plus years of proven experience in regulatory affairs or related roles within the food / dietary supplement and / or cosmetic industry with in-depth knowledge of FDA and FTC regulations relating to claims, labeling, and ingredient acceptability

Education Requirements :

Bachelor's Degree in science (Food Science, Biology, Chemistry, Biochemistry, or equivalent.) preferred, or a combination of education and equivalent work experience

Anticipated Pay Scale : $69,510 - $126,382 USD