Regulatory Affairs Professional
1 week ago
The position of Regulatory Affairs Manager is a critical role in the organization, responsible for all aspects of regulatory responsibilities in Singapore and Malaysia.
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.
- Interact with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business.
Requirements:
- 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.
- Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
- Ability to organize and analyze technical data and identify issues or gaps.
- Ability to work cross-functionally and manage multiple projects.
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