Regulatory Affairs Associate II at TEVA
Navi Mumbai, India
ID: 70316
A Teva Regulatory Affairs Job opportunity has emerged for aspiring professionals in the pharmaceutical industry as Teva Pharmaceuticals seeks a Regulatory Affairs Associate II in Navi Mumbai. This role offers an opportunity to contribute to high-quality regulatory submissions and compliance within a leading biopharmaceutical company.
About the Company
Teva Pharmaceuticals is a leading innovative biopharmaceutical company, recognized for its world-class generics business. The organization is dedicated to addressing patients’ needs through innovation in neuroscience and immunology, as well as delivering high-quality medicines globally. Teva fosters a high-performing, inclusive culture that values collaboration and fresh thinking, providing employees with opportunities for growth and work-life balance.
Teva Regulatory Affairs Job Details
- Job Title: Regulatory Affairs Associate II
- Location: Navi Mumbai, India
- Job ID: 70316
Job Description
In this Teva Regulatory Affairs Job, 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. The Associate II will be responsible for independently evaluating change controls (intended for post-approval changes), ensuring completeness and accuracy, and consulting with management prior to progressing the change control. Additionally, the role involves maintaining regulatory databases and trackers in real-time, as directed by management. Primary responsibilities include managing annual reports, supplements, and post-approval submissions.
Key Responsibilities
- Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
- Proactively request documentation required for annual reports, compile and publish for management review.
- Work independently on simple supplements, compile and publish for management review, and assist with more complex supplements.
- Further educate oneself on FDA Regulations by reviewing applicable post-approval guidance to assess change controls.
- Train Associate I’s on internal processes, procedures, databases, and trackers as needed.
- Undertake other projects and duties as required/assigned.
Eligibility for the Teva Regulatory Affairs Role
- M. Pharma degree in RA/QA discipline is a plus.
- Minimum 4+ years of pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory, or production experience preferred.
- Basic computer skills such as Word, Excel, and familiarity with the internet.
- Ability to work independently and collaboratively within teams.
- Good verbal and written communication skills.
- Must be well organized, detail-oriented, and capable of managing multiple tasks and changing priorities.
How to Apply
Interested candidates can apply through the following link:
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
This Teva Regulatory Affairs Job is a significant opportunity for qualified candidates to join Teva Pharmaceuticals as a Regulatory Affairs Associate II. Interested individuals are encouraged to apply before the deadline to be part of a company that values innovation and patient care.
