Regulatory Affairs Associate I

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

Under direct supervision, prepares regulatory submissions such as supplements, amendments to supplements and annual reports in accordance to FDA guidelines. The Associate I will be responsible for assisting in the evaluation of change controls as decided by the Manager or designee to assure accuracy of documents to be submitted. In addition, he/she will accurately populate and maintain any/all Regulatory or team databases and trackers in real time, as directed by their Manager or designee. Annual Report submission and all responsibilities associated will be the primary responsibility of the Associate I.

How You’ll Spend Your Day

• Under direct supervision, prepare annual reports, and as experience is gained, assist in supplements for FDA submissions.
• Under direct supervision, review documents included as support to change controls (i.e. as side by side review of batch records, methods, specifications etc.) for adequate review of the quality and appropriateness of the change control.
• Familiarizing oneself with applicable FDA Regulation and guidance to learn about filing determinations as they are used on the change control process.
• Other projects and duties as required/assigned.
• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual Reports.
  
  

Your Experience And Qualifications

• M. Pharma degree in RA/QA discipline, a plus.
• Minimum of two years Regulatory Affairs experience and/or analytical/QC, R&D/laboratory or production experience in pharmaceutical/biotech industry.
• Basic computer skills such as Word, Excel and familiarity with internet
• Ability to work independently and on teams
• Good verbal and written communication skills
• Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.
  
  

Make a difference with Teva Pharmaceuticals

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas 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 Tevas 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.

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