Regulatory Affairs Specialist (Fluent in Japanese)

Industry: Regulatory & Quality Admin.

Company: Partnerco

Who Are We?

Partner.Co is a global health and wellness company that partners with independent Brand Partners to help people achieve a body, business, and lifestyle they love. Through a process we call Partnership Marketing, we provide Brand Partners with everything they need to build their business, including high-demand products in the wellness, fitness, skincare, and personal care spaces, plus logistics, operations, marketing, and more. Our Brand Partners build their business by referring people to the suite of Partner.Co products are rewarded with money, travel, recognition, and fun events.

Our Culture

Partner.Co is headquartered in Puerto Rico, with our Innovation Center in Lehi, Utah, and offices worldwide. Our global presence allows our corporate staff to work with different cultures as we collaborate and grow as one high-performing, energetic team. We cultivate a collaborative culture where we work hard together and have fun while we do it! No matter your role, your impact is noted, and all ideas are encouraged.

We’re passionate about health! As an employee, you can join our Employee Transformation Group, where you can gain guidance, support and free products for your personal wellness goals, and, of course, friends to cheer for you along the way!

About the role

• Responsible for the submission of product registrations. Interacts and negotiates with regulatory agency personnel to expedite approval of pending registration. Serves as a regulatory liaison on the project team which includes R&D, Quality, Operations, Marketing and Sales in new product registrations and existing product marketing. Ensures that technical dossiers meet regulatory requirements. Provides advice on manufacturing changes, specifications, technical labeling, marketing, and appropriate regulations.

What you’ll do

• Coordinate efforts associated with preparation of regulatory submissions.
• Communicate with regulatory agencies regarding submissions under review and audits.
• Prepare and review regulatory submissions for country submissions.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review product promotional materials, labeling, specification sheets, or test methods for compliance with application regulations.
• Maintain current knowledge base of existing and emerging regulations, for markets under your responsibility.
• Prepare and maintain technical files as necessary to obtain and sustain product approval.
• Work with R&D, Operations, Sales, Marketing and Quality on new product launches in the markets under your responsibility.
• Assist in customs clearance as required in the markets under your responsibility.
• Key member in special projects as Greater China expert (Royalty agreement, export entity submission, foreign finished product supplier submission, foreign raw materials supplier submission, customs, imports & exports, government affairs, local OEM production).
• Other duties as assigned.

Required Skills and Abilities

• Strong interpersonal and communication skills.
• Proficient in Microsoft Office Suite.
• Ability to review technical files with accuracy and determine acceptability
• Independently lead the preparation and timely submission of regulatory filings.
• Work closely with all departments to coordinate regulatory submissions.

Education and Experience

• BS/BA degree in related field with experience in Regulatory Affairs
• Fluent in speaking and reading Japanese
• Knowledge of science, regulatory affairs and health
• Experience in Regulatory affairs
• • Knowledge of food/supplement ingredients and cosmetic ingredients
  • Knowledge of Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Practices (HACCP) and Adverse Event Reporting (AER).

The pay range for this role is:

55,000 – 85,000 USD per year (Utah Innovation Center)