Regulatory Services Manager APAC Pharma

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

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

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• How many years' experience do you have as a Regulatory Services Manager?
• How many years' experience do you have as a pharmacist?

We are the global market leader in chemical and ingredients distribution. Our more than 17,700 employees provide tailor‑made application, marketing and supply chain solutions. Our broad and diversified portfolio comprises industrial and specialty chemicals and ingredients of a world‑class supplier base. Building on its long‑standing experience, unmatched global reach and local excellence, Brenntag works closely alongside its partners to make their business more successful. Brenntag operates a unique global network with about 600 locations in 72 countries.

We are the global market leader in chemical and ingredients distribution. Our more than 17,700 employees provide tailor‑made application, marketing and supply chain solutions. Our broad and diversified portfolio comprises industrial and specialty chemicals and ingredients of a world‑class supplier base. Building on its long‑standing experience, unmatched global reach and local excellence, Brenntag works closely alongside its partners to make their business more successful. Brenntag operates a unique global network with about 600 locations in 72 countries.

Perks and benefits

• Medical
• Miscellaneous allowance
• Dental
• Parking
• Vision
• Outpatient Medical
• Insurance
• Performance Bonus

Researching careers? Find all the information and tips you need on career advice.