Regulatory Affairs Associate

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

The RA Associate II has the responsibility to compile and maintain the CMC part (modules 2.3 and 3) of the medicinal product dossiers for the worldwide registrations of TEVA.

How You’ll Spend Your Day

• Actively participate in meetings related to registration procedures or when CMC expertise is needed. Tightly collaborate with Submission RA functions for assigned products.
• Collect and critically evaluate data for inclusion in marketing authorization dossiers.
• Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements and trends.
• Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration.
• Respond to queries (from regulatory authorities or clients) concerning dossiers. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company (e.g. suppliers) and follow up agreed actions in order to respond as rapidly and completely as possible. Contribute to regulatory lifecycle management by:
• Actively participate in the change control system and variation process. Propose classification of the variations and adhere to the workflow established between Site RA and Submission RA functions.
• Evaluate changes and prepare the variation packages and other necessary documents as required by the variation process.
• Contribute to Technical Data Packages and participating actively in transfer teams as required.
• API: assess from a regulatory perspective the regulatory and technical drug substance documentation in case of second API source or update of Drug Master Files/CEP taking into account the quality of the material and of the documents already approved. Ensure that the documentation is appropriate for the required purpose and targeted countries. Liaise with the API supplier(s) as needed.
• Drug product: provide regulatory support to site units for QC and the Stability unit for creating or amending the products’ specifications or any other strategy or decision needed for supporting regulatory submissions.
• Contribute to renewal applications or annual reports.
• Respond to queries (from regulatory authorities, internal departments/affiliates or clients) concerning changes.
• Provide regulatory expertise and support, the main tasks being:
• Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and RoW) and pharmacopoeias.
• Provide information, support, and advice to TEVA’s internal departments/affiliates and clients on technical and regulatory topics concerning registration or post-approval change documents.
• Representing Site Regulatory Affairs in small project teams.
• Ensure that all documents and records pertaining to the Site RA Department are archived properly. Keep departmental database or other tracking systems up to date.
• Abide by the ICH guidelines and other relevant regulatory provisions, GMP requirements, occupational and environmental safety guidelines and internal SOPs, and ensure that all required training has been conducted and documented as appropriate.
• Create and keep updated the SOPs specific to the Site RA Department and ensure that the related training is performed and documented.
  
  

Your Experience And Qualifications

• University degree.
• Preferably be in possession of a master level of education in ‘Regulatory Disciplines’ or in other area, but pertinent with the field.
• 2-5 years of experience in CMC Regulatory Affairs or in another scientific role in the pharmaceutical industry
• Knowledge on registration procedures and pharmaceutical regulation
• Working independently with a moderate level of guidance and direction
• Very good command of English, speaking and writing.
• Good IT skills
• Ability to work in team.
• Communication skills with internal and external customers.
  
  

Enjoy a more rewarding choice

Alongside the fulfilling work, the inclusive culture and great rewards, our employees are entitled to a holistic benefits package, which is aimed to provide services required to their, and their families`, physical, emotional and social wellbeing.

In Teva, we understand that alongside your career and professional life, every employee has additional life circles, which include various private and family needs.

This is important to us, and has encouraged us to create one of the most unique and comprehensive benefits package that are offered in the Israeli market. Our benefits package is meant to support you and your family throughout the course of your life and career

Make a difference with Teva Pharmaceuticals

Reports To

Assoc Dir Regulatory Affairs

Already Working @TEVA?

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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.