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

• Mentor and provide guidance to Regulatory Affairs Executive or Officer.

Qualifications

• 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