Pharma Regulatory Affairs Lead — Submissions & Compliance

PT Brenntag; Shah Alam; On-site; MYR 134,000 - 201,000; Full time

Benefits offered by this job

Medical

Miscellaneous allowance

Dental

Parking

Vision

Outpatient Medical

Insurance

Performance Bonus

Job summary

PT Brenntag in Malaysia seeks a Regulatory Services Manager to guide product registrations, ensure compliance with local and international standards, and liaise with health authorities.

You will lead a small team, manage regulatory submissions, and provide advice to suppliers and internal teams. The role requires a licensed pharmacist, strong knowledge of GxP, and fluent English; a dynamic, collaborative mindset is essential.

Qualifications

• Licensed Pharmacist with current pharmacy license.
• Experience leading Regulatory Affairs and teams.
• Knowledge of GxP, drug registration, and regulatory submissions.
• Experience preparing regulatory documentation for pharma products.

Responsibilities

• Lead regulatory submissions and ensure compliance for pharma products.
• Coordinate with health authorities and internal teams.
• Maintain regulatory data and respond to information requests.
• Develop internal standards and training for regulatory processes.
• Monitor regulatory changes and advise on impact to business.
• Prepare product and supplier regulatory information packs.

Skills

Regulatory affairs leadership

Pharmacy license

Pharma regulations (GxP)

Regulatory documentation

English proficiency

Cross-functional collaboration

Education

Pharmacist degree

Job description

PT Brenntag in Malaysia seeks a Regulatory Services Manager to guide product registrations, ensure compliance with local and international standards, and liaise with health authorities.

You will lead a small team, manage regulatory submissions, and provide advice to suppliers and internal teams. The role requires a licensed pharmacist, strong knowledge of GxP, and fluent English; a dynamic, collaborative mindset is essential.