
Regulatory Affairs Expert
6 days ago
As a Regulatory Affairs Expert, you will play a pivotal role in ensuring our products meet the required legislative standards in Singapore and Malaysia.
The ideal candidate will have a strong understanding of regulatory requirements and submission processes in the specified markets.
- Key Responsibilities:
- Direct and support regulatory related matters such as new product registrations, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.
- Oversee creation of global regulatory product development strategies and preparation & submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements.
- Ensure compliance with product post-marketing approval requirements.
- Develop and advance the organization's policies and procedures related to regulatory affairs and compliance to foster a culture of adherence and regulatory integrity.
What We Are Looking For
- Minimum Degree in any Science course with minimum 5 years of experience.
- Proven experience in regulatory affairs within the pharmaceutical or medical device industry.
- Strong understanding of regulatory requirements and submission processes in the specified markets.
- Expert knowledge, understanding and application of principles, concepts and practices of government regulations.
Benefits
- Competitive salary and bonus.
- Flexible working model.
- Endless amenities and benefits.
Other Duties
- Manage product labelling in line with local regulatory guidelines.
- Review and approve advertisement and promotional materials to ensure compliance with local regulations and requirements.
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