Assistant Regulatory Affairs Manager

Description

Business partner

Liaise with Global/Regional RA for providing all required document, substantiation for submission to Thai FDA or relevant authorities to ensure regulatory compliance.
Manage the lifecycle of product licenses and registrations, ensuring all maintenance activities are completed on time.
Monitor, interpret, and communicate changes in regulatory legislation, guidelines, and standards, and assess their impact on company products and operations.
Actively contribute to the development and implementation of Regulatory Strategy for assigned projects
Support the development and implementation of comprehensive regulatory strategies for product development and commercialization across Thailand market.

Operational Effectiveness

Provide regulatory guidance and support to internal stakeholders e.g., Brand, Supply Chain, Quality Management, and Marketing, etc. throughout the product lifecycle.
Provide regulatory guidance to Global/Regional RA when reviewing documents e.g., formulae, product labeling, packaging, support document etc. to ensure full compliance with regulatory requirements.
Review and provide creative solution on advertisements, promotional material and marketing activities to ensure that the complaint with Thai FDA regulation or relevant regulations.

Business Process Improvement

Assist in process improvement initiatives within the Regulatory Affairs department to enhance efficiency and compliance.
Actively contributes to developing local process improvement to ensure work efficiency

External engagement

Appointed as representative of Company or the Cosmetic Industry Association regulatory authorities meeting or working groups

Build and maintain productive relationships with regulatory authorities to get their support as appropriate.
Interact with trade associations to obtain pre-emptive regulatory information.

Lead and Develop People

Degree holder with at least five (5) years related experience in compliance or similar role
Fluent English and Mandarin Chinese in writing and speaking, preferably with good project management experience and proficiency in Microsoft applications
Strong commitment to integrity, ethical business conduct and compliance
Ability to handle confidential matters in a highly discrete and sensitive manner, able to deal with ambiguity and uncertainties
Culturally sensitive team player with excellent business savviness, Able to confidently communicate and collaborate with stakeholders and partnering teams
Other preferred skills: ACAMS or equivalent compliance certifications, knowledge in Governance, Risk and Compliance system, and Project Management Tools