Kerja Sepenuh Masa, Regulatory Affairs Submission Excellence Specialist- Associate di Manpower Malaysia Selangor - Maukerja

About the Client

Our client is a leading global healthcare organization with a strong presence across international markets. The organization is committed to delivering innovative healthcare solutions and maintaining the highest standards of regulatory compliance across diverse regions. This role offers the opportunity to collaborate with global stakeholders, regional teams, and regulatory authorities while contributing to the successful registration and lifecycle management of healthcare products.

Job Responsibilities

Regulatory Leadership & Stakeholder Management

• Develop and maintain strong relationships with internal regulatory teams, affiliates, and distributors to ensure effective stakeholder management and operational excellence.
• Collaborate with affiliates and distributors to assess the impact of regulatory changes and ensure appropriate follow-up actions are implemented.
• Drive continuous improvement initiatives and optimize regulatory tools, systems, and ways of working.

Regulatory Submission & Dossier Management

• Prepare, evaluate, and dispatch regulatory dossiers for submissions in accordance with local regulatory requirements and agreed business priorities.
• Support the development of regulatory strategies in collaboration with key stakeholders to facilitate timely submissions and approvals.
• Stay informed on regulatory developments and assist in implementing required updates to processes and systems.
• Ensure the quality, accuracy, and completeness of regulatory dossiers prior to submission.
• Manage responses to regulatory authority deficiency letters by coordinating information gathering, review processes, and timely responses.
• Ensure timely dossier delivery to affiliates while balancing regulatory requirements, risk considerations, and business priorities.

Activity Tracking & Compliance Management

• Monitor and track planned dossier dispatches, renewals, and variation activities while supporting resolution of operational deviations.
• Maintain accurate regulatory records and provide timely updates for regulatory databases and repositories.
• Ensure proper tracking, archiving, and documentation of regulatory submissions and related activities.

Job Requirements

• Bachelor's Degree in Health Sciences, Life Sciences, Pharmacy, Regulatory Affairs, Medicine, Veterinary Science, or a related scientific discipline.
• Minimum 2 years of experience within the pharmaceutical, healthcare, or life sciences industry.
• Experience in Regulatory Affairs, including regulatory submissions, dossier preparation, product registrations, renewals, variations, or labeling activities.
• Strong understanding of regulatory requirements and compliance processes.
• Excellent written and verbal communication skills with strong presentation abilities.
• Ability to manage multiple priorities, work across international stakeholders, and meet regulatory deadlines.
• Detail-oriented with strong organizational, analytical, and problem-solving skills.
• Proficiency in spoken and written English; additional language capabilities would be advantageous.

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