Regulatory Associate
7 months ago
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**:
This role will be responsible to support product registrations, maintain compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products in Thailand
**Responsibilities include**:
**Support business growth**
- Completing NPD product registrations and NIP testing for NPD Dietary Supplement product.
- Low Risk Drug registrations
**Compliances, corporate policy and license life cycle management support**
- Reviewing product labelling in Content Hub and comply with FDA regulations
- Review recent DS product formulation to comply with new vitamin/mineral amount regulation
- Complete the mandatory FDA reports for drug products (monthly, quarterly and yearly)
- Variation submission of existing drug and DS products
- submit for renewal of current existing drug products which will be expired in October 2026 and herbal drug license.
**Special project work**
- Identify and contribute to any process improvements and efficiencies of Regulatory process
- Keep track on project progress and record
**Who are you?**
- 3-7 years experiences in Regulatory Affairs field.
- Qualified bachelor's degree or Pharmacist
- Strong communication skills including written and spoken English
- Understand regulations, guidelines and policies governing the healthcare industry (Pharmaceutical, Food, Cosmetic)
- Be able to evaluate relevant documents and determine appropriate action and able to provide the guidance and suggestion to other departments
- Ability to work independently in a dynamic and fast paced environment.
- Aptitude for identifying financial challenges and proposing solutions to improve performance and efficiency
- 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_
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