Regulatory Affairs Manager

Job Description: Regulatory Affairs Manager (Regulatory Compliance & Product Registration Lead)

Position: Regulatory Affairs Manager

Company Overview

Salus Bioceutical (Thailand) Co., Ltd. operates in the production, extraction, and complete laboratory analysis, research, and development of cannabis, hemp and other herbal products. The company focuses on high-quality Food Grade, Herbal, and Pharmaceutical products, certified by the Thai FDA under GMP/PIC/S standards. The company's goal is to become a leader in the cannabis/hemp and herbal industry in Thailand and Southeast Asia, providing a one-stop service for safe, reliable, and accessible products while positioning Thailand as a global cannabis, hemp and herbal hub for future health.

Role Purpose

Responsible for regulatory registration, licensing, renewal, and ongoing compliance of products, manufacturing facilities, and regulated operations including cannabis, hemp, herbal and plant-based products, pharmaceutical, dietary supplement, cosmetic, veterinary, and related products with relevant government authorities. The role also covers regulatory oversight of import and export activities for regulated products and substances, as applicable. This position ensures that the Company's products, sites, operations, and cross-border activities continuously comply with applicable laws, regulations, licensing conditions, and reporting requirements.

Key Responsibilities

• Manage regulatory registration, licensing, renewal, and approvals for products, manufacturing facilities, transportation, and regulated operations in compliance with applicable laws and regulations.
• Prepare, review, and submit regulatory documentation, ensuring accuracy, completeness, and compliance prior to filing with relevant government authorities.
• Plan and track regulatory submissions and approvals, and report regulatory status and outcomes to management.
• Monitor, interpret, and update applicable laws, regulations, and regulatory announcements, ensuring continuous compliance of products, facilities, and operations.
• Assess regulatory compliance risks and impacts, including new products, product or process changes, Change Control activities, labeling, and claims, and provide recommendations to management on appropriate compliance direction and risk mitigation measures.
• Manage regulatory requirements for transportation, distribution, import, and export of cannabis, hemp, and other regulated substances or products (including raw materials, extracts, reference substances, or other controlled inputs), covering permits, licensing conditions, mandatory reporting (e.g. SKYNET), customs documentation, and coordination with Thai and foreign regulatory authorities.
• Provide regulatory guidance and coordination to support licensing scope alignment, GMP/PIC/S inspection readiness, EU-GMP preparation, and international market entry, in collaboration with Production, Quality, and Management.
• Act as the primary regulatory contact, maintain regulatory records and databases, support inspections and audits, and perform other regulatory duties as assigned by management.

Additional Responsibilities (GMP/PIC/S compliance & Cannabis regulations)

• Ensure regulatory compliance and regulatory reporting obligations with Thai cannabis and hemp laws, including THC/CBD limits, FDA notifications, licensing conditions, and reporting obligations.
• Provide regulatory oversight on data integrity requirements (ALCOA+) for regulatory submissions and inspections under PIC/S and 21 CFR Part 11, in coordination with QA/QC.
• Review Batch Manufacturing and Packaging Records (BMR/BPR), yield, and reconciliation summaries for regulatory and registration purposes only, without quality release authority.
• Evaluate regulatory compliance of suppliers by reviewing GMP certificates, CoA, MSDS, and supporting supplier audits in collaboration with QA/QC.
• Support regulatory-related training and competency development, including contribution to Training Matrix for regulatory and compliance topics.
• Participate in risk assessment, root cause analysis (RCA), and CAPA activities by providing regulatory impact assessments in accordance with ICH Q9.
• Support quality and compliance improvement projects by providing regulatory input for validation, qualification, and change-related activities, in collaboration with QA/QC, Production, R&D, and Engineering.

Qualifications

• Bachelor's degree or higher in Pharmacy, Thai Traditional Medicine, Pharmaceutical Sciences, Biological Sciences, Chemistry, Food Science, or other related scientific fields.
• Experience in regulatory registration, licensing, and compliance of health products with the Thai FDA or other relevant government authorities.
• At least 2 years experience in Regulatory Affairs or regulatory compliance at a supervisor or manager level.
• Candidates without a professional license may be considered if they have strong hands-on experience in regulatory affairs, product registration, and ongoing regulatory compliance; a professional license (Pharmacist or Thai Traditional Medicine Practitioner) is an advantage.
• Experience reviewing regulatory-related quality and analytical documentation, such as specifications, CoA, validation summaries, and BMR/BPR for regulatory purposes.
• Experience working in pharmaceutical, herbal, cosmetic, or dietary supplement manufacturing environments (typically 46 years or equivalent exposure).
• Understanding of and/or experience in compliance with GMP/PIC/S, GHP, HACCP, ISO 9001, and ISO 17025.
• Excellent Thai writing skills for official and regulatory documentation, and effective communication in Thai and English.
• Strong analytical thinking, attention to detail, and systematic working style, with the ability to plan, prioritise, and work under pressure.
• Eligible to work legally in Thailand, with availability to support interactions with Thai regulatory authorities and prepare regulatory documentation in Thai and English, as required for the role.

Work Location

• Choeng Doi Subdistrict, Doi Saket District, Chiang Mai Province

Company Address

320 Moo 2, Ban Pho Thong Charoen, Highway 118, Chom Doi, Doi Saket, Chiang Mai 50220

Working Days & Hours

MondaySaturday (alternate Saturdays off), 08:0017:00

Benefits

• Travel allowance for work outside Chiang Mai
• Provident fund
• Group insurance
• Annual health check-up
• Performance bonus
• Ceremony support allowance
• Maternity support allowance
• Hospital visit gift
• Company uniform
• Team-building activities
• 15 public holidays per year
• Annual leave
• Other statutory leave entitlements in accordance with applicable labour laws

Application & Contact Information

Interested candidates are invited to submit their resume/CV and a brief cover note outlining relevant experience to the HR contact information below (with reference to this LinkedIn posting), or apply directly via this LinkedIn post. Shortlisted candidates will be contacted for further discussion

Contact

Human Resources Department

Salus Bioceutical (Thailand) Co., Ltd.

Email: [Confidential Information] / [HIDDEN TEXT]

Tel: 065-8261565