Regional Regulatory Affairs Manager
This position is responsible for product registration, evaluation of foreign regulations, appraisal of product formulations, communication of regulatory requirements to various functional groups, development of regulatory dossiers, and coordination of regulatory and marketing activities within local markets while communicating closely with top management teams. This position will primarily be responsible for the regulatory efforts required in our international markets with an emphasis on ASEAN region.
• Act as project manager over assigned registrations to ensure products are registered in support of market launch schedules.
• Assures that existing and new products comply with all laws, rulings and regulations affecting the use of ingredients, labelling and advertising.
• Monitors the development and assesses the impact of new and proposed changes in laws, rulings, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising. Submits comments on proposed changes to regulatory agencies as deemed appropriate. Communicates new requirements and changes within the organization, and assures compliance.
• Coordinate with Luxasia’s regulatory consultants, and in-country resources to develop local language labels and marketing materials.
• Helps identify and address potential patent and trademark issues in conjunction with in-house legal counsel.
• Assures that exported products comply with appropriate international formulation, labelling, advertising and product registration requirements.
• Assists Legal in researching and responding to issues related to litigation and other legal matters, as needed.
• Provides guidance to Marketing on new product concepts, claims and formulations to assure compliance with requirements.
• Performs other related duties as assigned.
Desired Skills and Experience
• Bachelor Degree or higher in one of the Life Sciences.
• Ability to analyze and evaluate complex legal and technical regulations.
• 8 – 10 years' experience working in a regulatory and/or technical environment is desirable, particularly as it pertains to the beauty field.
• Strong organizational skills, especially in the creation and maintenance of product dossiers and filing systems for Malaysia.
• Excellent communication skills (written and verbal) for effective interaction with all levels of division, company and external business partners, with a demonstrated capability for cultural sensitivity and understanding.
• Must be able to handle a high work load in an organized and efficient manner.
• Proven ability to manage support of outside design firms and analytical laboratories.
• Proven ability to manage projects across international markets, time zones, cultures, and functions.
• Proficiency with MS Office, MS Power Point, Excel and Outlook.
• Periodic travel may be required.