Global Regulatory Submissions Lead, Dossier & Lifecycle

Manpower Staffing Services (Malaysia) Sdn. Bhd.; Petaling Jaya; On-site; MYR 50,000 - 80,000; Full time

Job summary

Manpower Staffing Services (Malaysia) Sdn. Bhd. is seeking a Regulatory Affairs professional to lead submissions, dossier preparation, and lifecycle management in a global healthcare context.

You will collaborate with international stakeholders, ensure compliance, and manage multiple regulatory activities across regions. The ideal candidate has a minimum of two years in pharma or life sciences regulatory affairs, excellent communication skills, and the ability to balance priorities while meeting

Qualifications

• Bachelor’s degree in Health Sciences, Life Sciences, Pharmacy, Regulatory Affairs, Medicine, Veterinary Science, or a related scientific discipline.
• Minimum 2 years of experience in pharmaceutical, healthcare, or life sciences industry.
• Experience in Regulatory Affairs including 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 and meet regulatory deadlines across international stakeholders.
• English proficiency; additional languages helpful.

Responsibilities

• Lead regulatory activities and manage internal regulatory stakeholders.
• Coordinate with affiliates to assess regulatory changes and actions.
• Drive improvements to regulatory tools, systems and workflows.
• Prepare and dispatch dossiers per local regulatory requirements.
• Help develop regulatory strategies with key stakeholders.
• Monitor regulatory developments and update processes accordingly.
• Ensure dossier quality and completeness before submission.
• Coordinate responses to deficiency letters and data gathering.
• Deliver dossiers to affiliates on time while balancing priorities.
• Track and maintain regulatory records and databases.
• Archive and document regulatory submissions and activities.

Skills

Regulatory affairs

Stakeholder management

Communication skills

Multitasking

English proficiency

Education

Bachelor's Degree in Health Sciences / Life Sciences / Pharmacy / Regulatory Affairs

Job description

Manpower Staffing Services (Malaysia) Sdn. Bhd. is seeking a Regulatory Affairs professional to lead submissions, dossier preparation, and lifecycle management in a global healthcare context.

You will collaborate with international stakeholders, ensure compliance, and manage multiple regulatory activities across regions. The ideal candidate has a minimum of two years in pharma or life sciences regulatory affairs, excellent communication skills, and the ability to balance priorities while meeting