Regulatory Services Manager APAC Pharma

Brenntag; Shah Alam; On-site; MYR 120,000 - 240,000; Full time

Job summary

Brenntag Malaysia is seeking a qualified Pharmacist to lead regulatory affairs for the Pharma portfolio in APAC. You will guide the company through product registrations, maintain compliance, and liaison with health authorities to ensure legal market access.

You will supervise a regulatory team, prepare technical dossiers, monitor regulatory changes, and implement internal standards to uphold product safety and quality across markets.

Qualifications

• Knowledge of Pharma industry requirements and regulations (GxPs) and regulatory submissions.
• Experience leading a Regulatory Affairs team and coordinating cross-functionally.
• Fluent in English (spoken and written) with strong communication skills.
• Collaborative, team-oriented with ability to work across levels and functions.

Responsibilities

• Guide the company through regulatory processes for product registrations in APAC.
• Prepare, submit and maintain regulatory dossiers and technical information packs.
• Monitor regulatory changes and advise on impact to products and processes.
• Liaise with health authorities (KKM/MOH/FDA) and external stakeholders.
• Support suppliers and customers with regulatory, legal and quality information requests.
• Maintain regulatory data and contribute to KPI reporting.
• Develop internal standards, procedures and work instructions.

Skills

Regulatory affairs

Team leadership

English fluency

Communication

Education

Pharmacist license

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

The successful applicant will guides a company through the complex process of getting and keeping products legal and safe for market. They act as the bridge between the organization and health authorities (like the KKM, MOH, FDA etc ), managing submissions, tracking regulatory changes, and overseeing product compliance. Providing regulatory support and advice to suppliers, customers and Brenntag business, in order to be compliant with regulatory requirements, for the Pharma product range and geography assigned.

• Supporting the Pharma commercial teams on topics including regulatory, legal compliance, quality and product safety.
• Document preparation, handling product registration applications ensuring drugs are legally authorised for the markets intended.
• Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s).
• Contribute as part of team to maintain APAC document management system to keep product and supplier information up to date.
• Communicate with authorities, clients, suppliers and associates.
• Monitor regulatory legislation, environment, changing landscapes and implications for the organisation.
• Develop and implement internal standards, procedures and work instructions.
• Maintain and administrate regulatory data base and provide regulatory education and advice
• Request product and supplier information directly from manufacturers and indirectly via other internal channels.
• Process Change Control Notifications.
• Creation and ongoing update of product regulatory information in standardized information packs.
• Support of customer, regulatory and 3rd party risk assessments and audits.
• Reporting and documenting customer requests via KPIs.

Job Requirements

• Qualified Pharmacist holding a current Pharmacy License.
• Experience leading the Regulatory Affairs leading a team.
• Knowledge of Pharma industry requirements and regulations (GxPs, regulatory requirements around supply and end use of raw materials, excipients and active substances)
• Previous experience working with regulatory documentation for products supplied into the Pharma sector.
• Fluent in English (speaking and written)
• Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions