Regulatory Affairs Project Manager- South East Asia

Clinigen; Shah Alam; Hybrid; MYR 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Project Manager to join their dynamic team in Asia Pacific. This role is pivotal in ensuring regulatory compliance for new product registrations and variations, particularly within the South East Asia region. The ideal candidate will possess over 5 years of experience in regulatory affairs, with essential expertise in HSA and NRPA. This innovative firm offers a hybrid working environment, fostering collaboration and professional development. Join a team where your contributions will directly impact the success of regulatory submissions to health authorities, ensuring the highest standards of accuracy and clarity in documentation.

Benefits

Annual salary review

Performance bonus

13th month bonus

Opportunities for ongoing professional development

Employee Assistance Program

Paid Parental Leave

Qualifications

• 5+ years in regulatory affairs roles within South East Asia.
• Experience with HSA and NRPA is essential.

Responsibilities

• Ensure regulatory compliance for new product registrations.
• Contribute to the success of regulatory submissions.

Skills

Regulatory Affairs

HSA Experience

Analytical Skills

Team Collaboration

eCTD Publishing

Education

Tertiary qualification in a science or related field

Job description

Link, part of the Clinigen Group, is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, UK and EU, Asia Pacific and South Africa. We're growing rapidly and well positioned for an exciting future of continued expansion.

To support our growth, we are currently seeking a detailed orientated and collaborative Regulatory Affairs Project Manager to join our expanding team in Asia Pacific. You will be responsible for ensuring the organisation is meeting its regulatory compliance requirements for new product registrations and variations to existing registrations within assigned portfolio and territories. Experience with HSA and NPRA essential. Experience within other SEA markets desirable.

Your valuable work will contribute to the success of regulatory submissions to regional health authorities ensuring that all documents meet the highest standards of accuracy, clarity, and compliance.

Please note: this role will operate in a hybrid setting (two+ days per week onsite) if you are located nearby to our Shah Alam offices.

To be successful for this position, you'll need:

• A tertiary qualification in a science or related field
• 5+ years’ demonstrated experience in regulatory affairs roles within South East Asia
• Demonstrated experience working with the HSA and NRPA is essential, with exposure working with other regulatory agencies in the Asia Pacific region such as DOH or FDA highly advantageous
• Demonstrated experience with eCTD publishing experience
• Ability to critically evaluate, analyse and clearly communicate technical information
• Team-orientated, with a collaborative approach to the delivery of tasks and projects

In return, we can offer you:

• Annual salary review and performance bonus
• 13th month bonus
• Opportunities for ongoing professional development
• Employee Assistance Program
• Paid Parental Leave