Senior Regulatory Affairs Specialist

Teva Pharmaceuticals; Hong Kong Island; On-site; HKD 800,000 - 1,000,000; Full time

Job summary

A leading pharmaceutical company is seeking a Senior Regulatory Affairs Specialist in Hong Kong. The role focuses on ensuring compliance for new and existing products, coordinating with local and global partners, and managing product lifecycle changes. Ideal candidates will have a degree in Life Sciences and 2+ years of relevant experience in regulatory affairs. Excellent communication skills in English are essential.

Qualifications

• 2+ years of regulatory experience in pharma and regulated industry.
• Solid knowledge of local drug regulations.
• Fluent in written and spoken English.

Responsibilities

• Coordinate technical regulatory activities.
• Manage product lifecycle changes.
• Provide regulatory support for commercial activities.

Skills

regulatory compliance

communication skills

time management

attention to detail

Education

Basic Degree in Life Sciences

Tools

Microsoft Office

Job description

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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.

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?

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

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Wellness and Fitness Services, Biotechnology Research, and Pharmaceutical Manufacturing

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