Key Responsibilities:
- Prepare and review registration and variation dossiers for regulatory submissions, ensuring accuracy, scientific rigor, and adherence to documentation practices.
- Coordinate with international partners and regulatory consultants to support overseas registrations, aligning with company strategies and timelines.
- Work collaboratively with stakeholders on all aspects of product lifecycle management to ensure regulatory and quality compliance and support commercialization continuity.
- Maintain and update a database of relevant health product regulations, standards, and guidance documents, and interpret new regulations to assess their impact on products.
- Review promotional materials to ensure compliance with regulatory guidelines.
- Participate in regulatory inspections and internal audits both locally and abroad as needed.
- Develop and maintain effective relationships with local authorities and industry associations, providing regulatory support for clinical trials and ethics committee submissions.
- Assist with Good Distribution Practice (GDP) and quality assurance matters.
- Lead and support project teams to achieve business objectives.
- Help formulate regulatory strategies that align with registration timelines and business goals.
- Provide guidance and mentorship to junior regulatory affairs staff and interns to enhance their skills.
Qualifications:
- Degree in life sciences or pharmacy with 3 to 5 years of relevant experience; prior regulatory experience in a regional context is advantageous.
- Familiarity with international regulatory guidelines such as ICH, ASEAN, USFDA, and EU. Experience with food supplements or herbal medicine regulations in Europe, North America, or Asia Pacific is a plus.
- Strong understanding of GMP, GDP, and quality management systems is desirable.
- Resourceful with strong analytical and problem-solving abilities.
- Capable of prioritizing tasks and working efficiently in a fast-paced environment.
- Excellent team player with strong interpersonal skills.
- Experienced in mentoring interns or junior team members.
- Driven and results-oriented, able to coordinate effectively with internal and external stakeholders to meet deadlines.
- Flexible and adaptable to changing business objectives.
- Proficiency in English (both written and spoken) is required; additional language skills, such as Mandarin, are a significant advantage for liaising with external CMOs and partners.
Please be informed that if you are interested in applying for a position, please email your resume in either Word or PDF format to [email protected]. In your resume, kindly include the following details:
- Current Salary:
- Expected Salary:
- Availability:
- Reason for leaving your current job:
Thank you for your application. Please note that only shortlisted candidates will be contacted for further consideration.
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EA (23S1595/R23116355)
