Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Affairs Specialist - Manager (FSP)
Job ID R0000045897 , Hong Kong SARThe Regulatory Affairs Senior Specialist or Manager is responsible for supporting regulatory operations, submission execution, and lifecycle management activities for client's portfolio in Hong Kong and Macau.
This role works closely with internal stakeholders, external partners, and Heath Authorities to ensure timely submissions, regulatory compliances, and effective execution of regulatory activities.
This FSP role will need to be able to work at client's office (Location: Hong Kong)
Key Accountabilities:
- Prepare, submit, and track regulatory applications, including clinical trial applications, import permits, marketing applications, variations, and renewals.
- Support product registrations and post-approval lifecycle management activities.
- Coordinate regulatory submission activities with internal teams, external partners, and Health Authorities.
- Maintain regulatory documentation, submission records, and regulatory archives in accordance with company policies and local requirements.
- Support regulatory inspections, audits, and Health Authority requests as needed.
- Develop and maintain local regulatory procedures and working practices.
- Monitor local regulatory requirements and communicate relevant regulatory updates to stakeholders.
- Collaborate cross-functionally to support regulatory and business objectives.
Knowledge and Experience:
- With a minimum of 3-5-years regulatory affairs experience > Upon experience level, suitable title (Senior Specialist; equivalent to Senior Associate or up to Manager equivalent title) will be offered.
- Experience and knowledge in preparation of INDs and NDA/BLAs
- Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle
- Command of written and oral English, Cantonese, and Mandarin
- Travel: As required by the company.
Education:
- Minimum of a Bachelor’s Degree in a relevant study field
- Advanced Degree Preferred
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