Regulatory Affairs Specialist

POSITION SUMMARY

Regulatory Affairs Specialist for APAC region responsible for all things Regulatory in the region, including but not limited to ingredient review, marketing collateral review, product registrations, and label reviews. Understands, implements, and maintains the regulatory policy. Ensures compliance to and demonstrates knowledge of site and division-level policies and procedures.

SUPERVISORY RESPONSIBILITIES

This position has no supervisory responsibilities for this role.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for regulatory activities of APAC countries to launch and secure the products in the markets.
• Basic understanding of laws and regulations of the responsible APAC countries.
• Assisting the Director in responding to all product-related inquiries and actions by regulators and internal departments.
• Assisting in preparing and filing necessary documentation for applications with international government agencies for product registration and coordinating advice on technical aspects of product labeling, product dossiers, claims substantiation/localization, and product registrations.
• Reviewing marketing materials for compliance with advertising law and scientific substantiation.
• Reviewing product labels for compliance with APAC, ASEAN labeling regulations for medical devices, supplements, and cosmetics.
• Keep involved in the company’s continuous improvement program of waste minimization within a manufacturing system without sacrificing productivity.
• Manage Regulatory tools and trackers.
• Perform other related duties assigned by the supervisor.
• Obtains supervisory regulatory review on submission documents before submission to government agencies.
• Signs off at the team level within delegated parameters for change control.
• Releases authority for labeling/sales/promotional materials.
• Share knowledge with others in the department and on teams.
• Follows GMP guidelines and procedures.

PHYSICAL DEMANDS

While performing the duties of this job the employee is regularly required to remain in an office at a computer workstation and access information from a computer. The employee is required to be mobile to, from, and within the office. The employee may occasionally move up to 25 pounds.

LifeWave is committed to creating an inclusive workplace that values diversity and promotes equal opportunities for all. We embrace the principles of the Americans with Disabilities Act (ADA) and strive to provide reasonable accommodations to qualified individuals with disabilities.

In our pursuit of building a diverse and talented team, we encourage candidates of all abilities to apply for positions at LifeWave. If you require accommodation during the application or interview process, please inform our HR department, and we will work with you to ensure your needs are met.