Regulatory Affairs Associate
Blackmores Group is a leading natural health company with proud Australian heritage, with extensive reach across Asia Pacific. Founded by visionary naturopath Maurice Blackmore in 1932, our vision is to connect every person on earth to the healing power of nature by combining our knowledge of nature and science to deliver quality health solutions to people and their pets everywhere, every day.
As a purpose-led, performance-driven organisation, Blackmores Group strives to create remarkable employee experiences through supporting a diverse and inclusive culture, creating leadership that inspires high performance, and providing everyone with opportunities to achieve their professional, personal and wellbeing goals supported by our flexible work practices and family friendly policies.
Purpose of role:
The role is responsible to drive the on-time development of regulatory documentation for commercially successful products. Complete product registrations, maintain compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products in Thailand.
Responsibilities include:
- Assess product formulations and determine regulatory registration requirements and feasibility.
- Prepare, review, and compile registration dossiers to ensure completeness and compliance for submission to regulatory authorities.
- Review, update, and maintain product labelling in accordance with FDA regulations and guidelines.
- Monitor regulatory changes and evaluate the impact on product formulations and registrations.
- Prepare and submit mandatory FDA regulatory reports for pharmaceutical products, including monthly, quarterly, and annual submissions.
- Manage variation applications for registered drug and food/dietary supplement products, ensuring timely approval and regulatory compliance
Who are you?
Bachelor’s Degree in Science, Pharmacy, Regulatory Affairs, or a related discipline.
3 to 5 years of Regulatory Affairs experience, preferably in food, dietary supplements, pharmaceuticals, or healthcare products.
Good understanding of regulatory requirements, guidelines, and policies across pharmaceutical, food, and cosmetic products.
Knowledge of manufacturing processes, quality systems, and ASEAN Harmonisation documentation requirements.
Strong written and verbal communication skills in English.
Ability to review regulatory documentation, assess compliance risks, and provide appropriate recommendations.
Detail-oriented with strong analytical skills and the ability to provide regulatory guidance to stakeholders while managing multiple submissions and deadlines.
Agencies please note: this recruitment assignment is being managed directly by Blackmores Talent Acquisition team. We will reach out to our preferred agency partners if required. Your respect for this process is appreciated.