Regulatory Affairs Associate II at Teva Pharmaceutical Industries Ltd. - Israel

Kfar Saba, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

0.0

Posted On

10 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, CMC, Quality Assurance, Drug Development, Analytical Skills, Team Collaboration, Multi-tasking, Problem Solving, Communication, Knowledge of Regulations, Experience with Sterile Products, Experience with Medical Devices, Database Management, Project Management, English Proficiency, Hebrew Proficiency

Industry

Pharmaceutical Manufacturing

Description

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 This section is where we attract the attention of potential candidates and sell the role. How has the role come about? What makes it appealing? What are the key responsibilities? How is the role better with Teva than with another company? Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we’re in it together, and we make work fulfilling.How you’ll spend your day Collection and preparation of documents intended for submission of CMC variation packages Evaluation of changes and support for their implementation in drug documentation for EU, US, IL market, as well as monitoring the status of requests and agreed activities Participation in meetings for projects within responsibility and informing other organizational units about the content of the registration file 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 Preparation of responses to authorities’ requests within regulated timeframe Update status through electronic systems, database and relevant forums Your experience and qualifications University degree (Pharmacist/Biologist/Chemist/ Engeneering/ Biomedical) 2-3 years of experience in regulatory affairs in CMC, quality assurance and control, drug development or analytics will be an advantage Experience of working with Multi-national companies in Pharmaceuticals Knowledge in regulation, requirements and guidelines Proficiency in written and spoken English and Hebrew Ability to work in dynamic environment, multi-tasking, Ability to work both individually and in the team, to cooperate on cross-country level and with different business units Experience in global environment- advantage Experience with sterile products Experience with medical device combined product- advantage Knowledge with electronic systems and databases Make a difference with Teva Pharmaceuticals Reports To Assoc Dir Regulatory AffairsAlready 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.

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Responsibilities

The role involves the collection and preparation of documents for CMC variation packages and evaluation of changes in drug documentation for various markets. Additionally, the associate will provide regulatory input throughout the product life cycle and prepare responses to authorities’ requests.