Regulatory Affairs Job at Teva | MPharma Graduates Apply Now
Teva Pharmaceuticals is hiring a Regulatory Affairs Associate I for its facility in Navi Mumbai, India. This Regulatory Affairs Job is ideal for candidates with a Master of Pharmacy (M. Pharm) degree and at least two years of experience in the pharmaceutical or biotech industry. Working under direct supervision, the Associate will focus on preparing FDA submissions, including supplements, amendments, and ANDA Annual Reports. The role requires strong attention to detail and proficiency in maintaining regulatory databases and trackers in real-time.
- Job Title: Regulatory Affairs Associate I
- Location: Navi Mumbai, India, 400706
- Job ID: 65573
About The Company
Teva Pharmaceuticals is the world’s leading manufacturer of generic medicines and a major producer of essential healthcare products on the World Health Organization’s Essential Medicines List. Operating across nearly 60 countries, Teva helps approximately 200 million people gain access to quality, affordable medicines every single day. The company is committed to a diverse and inclusive workplace, fostering a global mission to make good health more accessible through both innovative biopharmaceuticals and an industry-leading generics business.
Job Opportunity
Under direct supervision, prepares regulatory submissions such as supplements, amendments to supplements, and annual reports in accordance with FDA guidelines. The Associate I in this BPharm Job 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.
Responsibilities of the Regulatory Affairs Job
- 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 by side review of batch records, methods, specifications, etc.) for adequate review of the quality and appropriateness of the change control.
- Familiarize oneself with applicable FDA regulations and guidance to learn about filing determinations as they are used in 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 the RA/QA discipline, a plus for this BPharm Job
- Minimum of two years Regulatory Affairs experience and/or analytical/QC, R&D/laboratory or production experience in the pharmaceutical/biotech industry.
- Basic computer skills such as Word, Excel, and familiarity with the internet.
- Ability to work independently and in teams.
- Good verbal and written communication skills.
- Must be well organized, detail-oriented, and have the ability to multitask and manage changing priorities.
