Regulatory Services Manager APAC Pharma

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

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

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,