Regulatory Services Manager - APAC Pharma

About the role

Brenntag is looking for a Regulatory Services Manager for its APAC Pharma business. The role guides the company through the complex process of getting and keeping products legal and safe for market, acting as the bridge between the organization and health authorities such as the KKM, MOH and FDA. It manages submissions, tracks regulatory changes and oversees product compliance, providing regulatory support and advice to suppliers, customers and Brenntag business for the assigned product range and geography.

Key responsibilities

• Support the Pharma commercial teams on regulatory, legal compliance, quality and product safety topics.
• Prepare documents and handle product registration applications so drugs are legally authorised in their target markets.
• Complete technical and regulatory information requests from customers, including questionnaires, supply chain agreements, QAA's and TA's.
• Contribute to keeping the APAC document management system up to date with product and supplier information.
• Communicate with authorities, clients, suppliers and associates.
• Monitor regulatory legislation and its implications for the organisation.
• Develop and implement internal standards, procedures and work instructions.
• Maintain and administer the regulatory database, provide regulatory education and advice, and request product and supplier information from manufacturers.
• Process change control notifications and create and update standardized product regulatory information packs.
• Support customer, regulatory and third-party risk assessments and audits, and report customer requests via KPIs.

Required profile

• Qualified pharmacist holding a current pharmacy license.
• Experience leading a regulatory affairs team.
• Previous experience with regulatory documentation for products supplied into the pharma sector.
• Fluent English, spoken and written.
• Team player with strong communication and interpersonal skills, able to work across all levels and functions.

Required skills

• Knowledge of pharma industry requirements and regulations, including GxPs.
• Understanding of regulatory requirements around supply and end use of raw materials, excipients and active substances.