Senior Regulatory Affairs Associate

Date: Jan 17, 2024

Location: 

Bangkok, Thailand, 10110

Company: Teva Pharmaceuticals

Job Id: 53597

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

Teva Pharmaceuticals is currently in need of a dynamic and highly motivated Senior Regulatory Affairs Associate.

How you’ll spend your day

• Coordinate with global regulatory teams and local health authorities on pre-dossier procedures, product dossier registration submission and approvals including all variations
• Provide regulatory and technical perspectives to regulatory team and other departments on product registration, submission, approval and all variations
• Understand regulations, technical guidelines, and policies from the local health authorities and update regulatory team on regulations, guidelines, and procedures
• Work with regulatory team and other functions to create solutions and implement agreed mitigation plans
• Provide regulatory input throughout the product life cycle of responsible product lines and understand or raise regulatory obstacles to Head of regulatory Function
• Work closely with local health authorities throughout the product life cycle of responsible product lines, provide documents as authorities’ requests within regulated timeframe, submit required reports regulated by the authorities within regulated timeframe, anticipate any risk & impacts of regulatory matters and inform Head of Regulatory Function
• Supervise junior regulatory staff

Your experience and qualifications

• Bachelor’s degree in Pharmacy
• 5 years of experience with generic, new generic and/or new drugs registration
• Experience of working with Multi-national companies in Pharmaceuticals
• Have good knowledge of Thailand regulatory authorities, laws, regulation, requirements and guidelines
• Understand technical point of view including product development, bioequivalence, product quality, safety and efficacy
• Proficiency in written and spoken Thai and English languages
• Good interpersonal and negotiation skills

Make a difference with Teva Pharmaceuticals

If you believe you have what it takes to succeed in this role, apply to Teva today!

Please submit your CV and a Cover Letter.

Please note that only shortlisted candidates will be contacted.

Reports To

Senior Regulatory Affairs Manager

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.