Regulatory Affairs Specialist (Shah Alam)

A leading organisation in Shah Alam is seeking a Regulatory Affairs Specialist to provide focused regulatory and documentation support for APIs and excipients supplied to Malaysian pharmaceutical manufacturers. This pivotal role ensures complete and compliant API excipient dossiers for both local and international finished drug product registrations, supporting customers’ timely market access across all dosage forms.

What you'll do:

As a Regulatory Affairs Specialist based in Shah Alam, you will be responsible for providing expert support throughout the entire regulatory process for APIs and excipients used by pharmaceutical manufacturers. Your day-to-day activities will involve coordinating complex documentation workflows—ensuring that dossiers are accurate, up-to-date, and fully compliant with both local Malaysian regulations as well as international standards. You will collaborate closely with internal teams such as sales, product management, sustainability functions, S&OP departments; externally you’ll interact with suppliers, customers, competent authorities. By centralising these responsibilities within your remit you’ll enhance communication channels between stakeholders—reducing delays while strengthening overall compliance across product lines. Occasionally you’ll extend your expertise into adjacent sectors like food/feed safety or chemical substance distribution—assisting local teams with registration planning or document preparation when needed. Your ability to manage multiple requests simultaneously while maintaining high attention to detail will be crucial for success in this role.

• Provide comprehensive regulatory support to Malaysian and APAC pharmaceutical manufacturers by overseeing API/excipient product registration, compliance checks, and renewal processes for both local and international markets.
• Coordinate the provision of Common Technical Documents such as Drug Master Files (US DMF, ASMF) and Certificates of Suitability (CEPs), ensuring alignment with customer needs and authority requirements.
• Review, verify, and quality-check all regulatory documentation received from API/excipient suppliers including DMFs, CEPs, technical dossiers, GMP certificates, stability data, and quality agreements to ensure accuracy and completeness.
• Manage lifecycle activities for DMFs/CEPs by addressing deficiencies or updates issued by authorities through corrective actions, additional testing, or dossier updates with suppliers to maintain ongoing customer compliance.
• Act as the internal regulatory liaison during product launches, customer qualification processes, tender requirements, and business development initiatives to facilitate smooth transitions and successful outcomes.
• Respond promptly to customer and health authority queries related to API regulatory status, compliance matters, and documentation requests with clear communication.
• Coordinate product registration activities in collaboration with in-country teams and external partners while monitoring relevant regulatory changes that impact commercial and supply chain stakeholders.
• Provide guidance on chemical legislation relevant to distributed products including food/feed safety compliance, food contact material regulations, GHS classification standards, and chemical inventory requirements.
• Assist in compliance assessments for new product introductions, supplier onboarding procedures, and product substitutions to ensure legality and marketability across regional markets.
• Serve as the central point of contact for customers, suppliers, and internal teams regarding technical issues or compliance matters while improving process efficiency by centralising documentation flows.

What you bring:

Your proven experience as a Regulatory Affairs Specialist will include deep familiarity with pharmaceutical industry standards—particularly around API/excipient registration processes—and strong exposure to both Malaysian-specific regulations (NPRA) as well as international submission protocols. You bring advanced academic credentials in life sciences coupled with practical experience navigating complex legislative frameworks governing chemicals/food/feed/contact materials. Your interpersonal skills enable you to build trust-based relationships across diverse stakeholder groups—from internal colleagues through external partners/customers/regulatory bodies. You excel at technical writing/documentation tasks where precision matters most; your ability to juggle competing priorities without sacrificing quality sets you apart from others. Fluency in English ensures seamless communication; any additional languages further enhance your value proposition.

• A life science degree at Master or PhD level such as chemistry, food technology or pharmaceutical sciences is required for this position.
• 3-5 years of work experience within the Pharma or Chemical sector with exposure to relevant regulations is essential for success.
• Demonstrated knowledge of Drug Master Files (USDMF/CTD) and Certificates of Suitability (CEPs) is necessary along with familiarity with NPRA requirements.
• Experience handling Malaysian or international regulatory submissions is highly valued alongside understanding of API-related GMP principles.
• Awareness of other chemical legislation frameworks including food/feed safety compliance or food contact material regulations is beneficial.
• Proven track record working collaboratively with regulatory authorities as well as suppliers/manufacturers is expected.
• Exceptional documentation skills combined with technical writing abilities plus high attention to detail are mandatory.
• Effective communication skills enabling coordination across customers/suppliers/internal teams are vital for this role.
• Ability to manage multiple regulatory requests/timelines efficiently while maintaining composure under pressure is important.
• Fluency in English (spoken/written) is required; additional language skills are considered an asset.

What sets this company apart:

This organisation stands out due to its unwavering commitment to product safety and regulatory excellence across all sectors it serves. Employees benefit from flexible working arrangements that accommodate personal needs while fostering communal growth within supportive teams led by knowledgeable managers who prioritise training opportunities. The company’s dedication to continuous improvement means you’ll always have access to resources that help advance your career—whether through formal learning programmes or informal knowledge-sharing sessions among peers. Its inclusive approach ensures everyone feels valued regardless of background; collaboration is encouraged at every level so ideas can flourish freely without hierarchy impeding progress. With a reputation built on dependability/trustworthiness plus strong customer orientation—the company provides an environment where your contributions truly matter toward achieving shared goals together.

What's next:

If you’re ready to make a meaningful impact in pharmaceutical regulation while enjoying flexible working opportunities within a supportive team environment—this could be the perfect next step for your career!

Apply today by clicking on the link provided below.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C