Global Regulatory Affairs Project Lead
2 weeks ago
Clinigen, a leading global specialty pharmaceutical services business, is seeking an experienced Regulatory Affairs Project Manager to join our expanding team in Asia Pacific. This key role will play a crucial part in ensuring the organisation meets its regulatory compliance requirements across new product registrations and variations within assigned portfolios and territories.
The successful candidate will be responsible for managing the preparation and submission of high-quality regulatory documents to regional health authorities, adhering to strict standards of accuracy, clarity, and compliance.
Key responsibilities include:
- Managing regulatory submissions to ensure timely and accurate delivery
- Coordinating with internal stakeholders to obtain necessary documentation and information
- Developing and implementing strategies to improve regulatory compliance
We are looking for a detail-oriented and collaborative individual with:
- A tertiary qualification in a science or related field
- At least 5 years' experience in regulatory affairs roles within South East Asia
- Demonstrated expertise working with HSA and NPRA, with exposure to other regulatory agencies in the Asia Pacific region highly advantageous
- Experience with eCTD publishing and critical evaluation of technical information
In return, we offer:
- Competitive salary review and performance-based bonuses
- Ongoing professional development opportunities
- Employee Assistance Program and paid parental leave benefits
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Shah Alam, Selangor, Malaysia Clinigen Full timeLink, 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...
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