Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunity
A full-time position for Hong Kong to work on new submission / maintenance / labelling / regulatory compliance.
Collaborate with Quality, Supply Chain and Commercial Team.
Involvement in multinational regulatory issues and with concepts of regulatory strategy.
Ensure that all new products are registered according to local authority regulations and corporate policy as well as maintaining the MA of the existing products.
Ensure labeling (including local repackaging components) of all products introduced in the local market are compliant to local regulatory requirements and Corporate Guidelines.
Ensure that all changes in particulars and renewal of registered products as required by the local Health Authorities which are in compliance with corporate policy and the local Authorities’ regulations.
Collaborating with local partners in Macau comply with regulations on medicinal products.
How you’ll spend your day
New Product / Project Registration:
- Coordinate and support technical and scientific regulatory activities.
- Communication with oversea counterpart for necessary dossiers and documents for submissions.
- Work with global RA and business partners of updating submission progress.
Lifecycle Management:
- Plan and manage product lifecycle changes.
- Coordinate and monitor artwork / packaging process of variation of existing products.
- Review and update Patient Information Leaflet in accordance with local regulatory requirements / company guideline.
Business Support:
- Provide regulatory support for commercial activities, e.g. registration information for tender submission.
- Review of marketing materials. Ensure promotional materials are complied with the requirements of Undesirable Medical Advertisement Ordinance (UMAO) and DoH registration guidelines.
RA Processes:
- Ensure that processes are clearly defined in SOPs for all critical tasks/duties e.g. regulatory filings, artwork, etc;
- Establish and review local SOP/WIs;
- Maintain good record, databases, data of product registration and licenses per company guideline
Your experience and qualifications
- Basic Degree in Life Sciences specialties, e.g. Pharmacy, Medicine, Biological Sciences
- Preferably 2 or more years of regulatory experience in pharma and regulated industry
- Experience in registration of medicinal products
- Flexibility to work in a cross-cultural environment
- Basic knowledge in drug development, pharmacovigilance, GxP processes, QA would be advantageous
- A good balance of Regulatory and Business acumen
- Solid knowledge and understanding of local drug / healthcare regulations and ability to apply them at work effectively
- Good communication skills, fluent in written and spoken English in additional to local language to interact effectively with the government agencies in the country
- Able to work under pressure and to tight timelines
- Effective time management and multi-tasking
- Flexibility in working schedule
- Spontaneous team player and collaborator
- Flair to simplify complex issues and manage project efficiently
- Attention to details and logical analytical skills
- Computer literacy
- Demonstrated ability to handle competing priorities effectively
- Results oriented, business-oriented and self-motivating
- Openness to change and ability to think out of the box
Make a difference with Teva Pharmaceuticals
Please submit your CV and a cover letter responding to the selection criteria outlining relative keys skills and experience in relation to this role.
Please note that only shortlisted candidates will be contacted.
Reports To
Head of Regulatory Affairs, Hong Kong & Taiwan
Already Working @TEVA?
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