Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Assess food supplement formulations to ensure compliance with regulatory standards in global markets.

• Investigate and interpret relevant legislation, guidance documents, and regulatory frameworks.

• Offer regulatory advice concerning ingredients, product claims, formulations, and labeling requirements.

• Track regulatory changes and communicate their implications to internal stakeholders.

• Prepare and manage regulatory dossiers and documentation necessary for registrations, notifications, and market access initiatives.

• Create country-specific regulatory documentation for worldwide product launches.

• Assist with registration and notification procedures in designated international markets.

• Collect, organize, assess, and sustain regulatory information.

• Inspect product labels and packaging content for compliance with local market regulations.

• Assess marketing and product claims for adherence to regulatory standards.

• Facilitate necessary labeling updates due to regulatory changes.

• Oversee multiple regulatory projects while adhering to business timelines and market launch goals.

• Collaborate with internal teams, clients, consultants, and regulatory bodies.

• Promote the ongoing enhancement of regulatory processes, policies, and systems.

• Act as a regulatory resource for Marketing, R&D, Quality, Supply Chain, and Commercial teams.

• Uphold company, departmental, and safety policies, procedures, programs, and activities.

• Maintain a tidy and organized work environment.

⛳️ Requirements

• Bachelor's or Master’s degree in Food Technology, Food Science, Nutrition, Regulatory Affairs, or a related scientific field.

• Capability to research, interpret, and apply international legislation, regulatory guidance, and scientific literature.

• Proficiency in evaluating food supplement formulations, ingredients, labeling content, and product claims across various international markets.

• Competence in preparing, reviewing, and maintaining regulatory dossiers, registration files, notifications, and relevant documentation.

• Ability to review technical and scientific documents, identifying inconsistencies, omissions, compliance risks, and documentation gaps.

• Skill in prioritizing and advancing multiple projects with competing deadlines.

• Excellent written and verbal communication skills.

• Proficient in gathering, organizing, evaluating, and maintaining regulatory information from diverse sources.

• Familiarity with Microsoft Word and Excel, with the ability to learn company and industry-specific systems.

• Fluency in English, both written and spoken.

• Experience in regulatory affairs, food supplement compliance, product registration, food science, or a related area (preferred).

• Background in supporting food supplement registrations, notifications, or market access initiatives in international markets (preferred).

• Knowledge of European Union and other international food supplement regulatory requirements (preferred).

• Experience in preparing regulatory dossiers and country-specific registration documentation (preferred).

• Familiarity with regulatory databases, document management systems, or product lifecycle management systems (preferred).

🏝️ Benefits

• Access to our Employee Health Clinic for your medical needs.

• Comprehensive Medical, Dental, and Vision Insurance coverage.

• Participation in our Family First Program, emphasizing work-life balance.

• 401(K) plan with generous employer match to help you plan for the future.

• Educational Reimbursement opportunities to support your continued learning and development.

• Wellness Incentives to promote a healthy lifestyle.

• Substantial product discounts.

• Generous Paid Time Off and Paid Holidays.