Senior Regulatory Affairs Specialist

Who we are

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 youll 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

If you are a current Teva employee please apply using the internal career site available on Employee Central. By doing so your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

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