Regulatory Affairs Job at Teva Pharmaceuticals | MPharm Graduates Apply Now
Teva Pharmaceuticals is hiring a Regulatory Affairs Associate II for its office in Navi Mumbai, India. This Regulatory Affairs Job is designed for professionals with a minimum of four years of pharmaceutical industry experience, particularly those with an M.Pharm in RA/QA. The Associate II in this Teva Job will lead critical regulatory activities, including the preparation and submission of ANDA Annual Reports and FDA supplements, while managing post-approval change controls in a high-compliance environment.
- Job Title: Regulatory Affairs Associate II
- Location: Navi Mumbai, India, 400706
- Job Id: 64918
About The Company
Teva Pharmaceuticals is the world’s leading manufacturer of generic medicines and a proud producer of many products on the World Health Organization’s (WHO) Essential Medicines List. Operating in nearly 60 countries, Teva serves at least 200 million people every single day. The company is on a mission to make good health more affordable and accessible through a diverse and inclusive global workforce for those seeking regulatory affairs positions.
The opportunity
The Associate II, with moderate to minimal guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines. Those considering a regulatory affairs job will find that the Associate II in this role will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and will consult his/her manager/designee prior to progressing the CC. 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 reports, supplements and post approval submissions will be the primary responsibilities of Associate II.
Responsibilities
- Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
- Under minimal supervision, proactively request documentation required for annual reports, compile and publish for management’s review.
- Under management’s direction/assignment, work independently on simple supplements, compile and publish for management’s review. Assist management on more complex supplements to gain experience.
- Further educate oneself on FDA Regulations by reviewing any/all applicable post-approval guidance’s to understand and accurately assess change controls necessary for a regulatory affairs position.
- When needed, train Associate I’s on internal processes, procedures, databases, and trackers related to a regulatory affairs role.
- Other projects and duties as required/assigned
Experience and Qualifications
- M. Pharma degree in RA/QA discipline, a plus for the Teva Job
- Minimum four years plus pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred for those seeking Regulatory Affairs jobs.
- Basic computer skills such as Word, Excel and familiarity with the 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.
