Regulatory Affairs Leader — Pharma Compliance & Submissions

Brenntag Sdn Bhd; Kuala Selangor; On-site; MYR 120,000 - 160,000; Full time

Benefits offered by this job

Medical

Miscellaneous allowance

Dental

Parking

Vision

Outpatient Medical Insurance

Performance Bonus

Job summary

Brenntag Sdn Bhd is seeking a Regulatory Affairs Lead Pharmacist to guide regulatory submissions and ensure compliance for pharma products in assigned geographies. The role requires leading a regulatory team, deep knowledge of GxP requirements, and effective communication with authorities and internal stakeholders.

You will monitor regulatory changes, maintain documentation, and provide regulatory guidance to suppliers and customers to support Brenntag’s pharma portfolio.

Qualifications

• Qualified Pharmacist with current license.
• Experience leading regulatory affairs and teams.
• In-depth knowledge of pharma regulations (GxPs) and supply/end-use requirements.

Responsibilities

• Guide the company through regulatory submissions and product registrations.
• Maintain APAC regulatory document management and keep supplier/product information up to date.
• Communicate with health authorities, clients, suppliers and internal teams.
• Monitor regulatory changes and implications for the organisation.
• Develop and implement internal standards, procedures and work instructions.
• Provide regulatory education and advice to stakeholders.

Skills

Regulatory affairs leadership

GxP knowledge

English proficiency

Education

Pharmacist license

Job description

Brenntag Sdn Bhd is seeking a Regulatory Affairs Lead Pharmacist to guide regulatory submissions and ensure compliance for pharma products in assigned geographies. The role requires leading a regulatory team, deep knowledge of GxP requirements, and effective communication with authorities and internal stakeholders.

You will monitor regulatory changes, maintain documentation, and provide regulatory guidance to suppliers and customers to support Brenntag’s pharma portfolio.