Regulatory Affairs Director APAC
3 days ago
The Opportunity
As a senior regulatory professional, you will play a key role in ensuring the compliance of Abbott's products in the Asia Pacific region. You will be responsible for developing and implementing regulatory strategies, managing regulatory professionals, and providing expert advice to executive management. Your expertise will be essential in navigating the complex regulatory landscape and ensuring that our products meet the required legislation.
Key Responsibilities
- Develop and implement regulatory strategies for APAC region
- Manage a team of regulatory professionals to ensure compliance and regulatory excellence
- Provide expert advice to executive management on regulatory matters
- Ensure that products are developed, manufactured, and distributed in compliance with regulatory requirements
- Develop and maintain relationships with regulatory authorities and trade associations
- Stay up-to-date with changing regulations and guidance
- Ensure that data are identified, obtained, and effectively presented for product registration
- Develop and implement processes and SOPs to ensure compliance
- Recruit, develop, and manage regulatory professionals
- Provide guidance on resource and development planning
- Approve regulatory filing strategies
- Review and approve labeling to ensure compliance
- Represent regulatory affairs in product recall and recall communication process
- Provide strategic input and technical guidance on regulatory authority queries
- Oversee processes involved with maintaining annual licenses, registrations, listings, and patent information
- Create project plans and timelines
- Lead cross-functional groups in the development of relevant data to complete a regulatory submission
Requirements
- Bachelor's Degree in science, math, or medical field
- Minimum 5 years' experience in a regulated industry
- Masters in technical area or MBA preferred
- Minimum 5+ years' experience in regulatory affairs
- Experience working with Medical Devices, software, or combination products
- Experience working in supporting APAC region
- Ability to communicate both orally and in writing in Chinese, Japanese, and/or other Asian language
- RAPS Certification
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