Regulatory Affairs Associate III Job Details Teva Pharmaceuticals- Navi Mumbai-teva Pharmaceuti[...]

teva pharmaceuticals ltd; Navi Mumbai; On-site; INR 8,00,000 - 12,00,000; Full time

Job summary

A leading pharmaceutical company in Navi Mumbai is seeking a Regulatory Affairs Associate III. The ideal candidate will have 7-9 years of experience in the Pharmaceutical Industry, expertise in regulatory submissions, and a strong understanding of ICH and FDA guidelines. Responsibilities include managing regulatory documentation, ensuring compliance with FDA regulations, and training junior associates. This role requires excellent communication and organizational skills, along with a detail-oriented mindset.

Qualifications

• 7-9 years of experience in the Pharmaceutical Industry.
• Minimum 6 years of RA experience preferred.
• Understanding of ICH and FDA guidelines.

Responsibilities

• Maintain approved applications in compliance with FDA regulations.
• Request documentation required for annual reports.
• Independently work on supplements and compile for management's review.

Skills

Regulatory knowledge

Analytical skills

Communication skills

Organizational skills

Problem-solving

Detail-oriented

Education

Bachelor's in pharmacy or master's in pharmacy

Master in science & Life sciences

Job description

Overview

Regulatory Affairs Associate III at Teva Pharmaceuticals. Location: Navi Mumbai, India. Date: Aug 20, 2025. Job Id: 63583.

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. Its 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 worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations 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

The Associate III, with minimal to no guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines. The Associate III will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly. In addition, he/she will monitor any/all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required. Annual Reports, supplements, post approval submissions and assisting management with the training of regulatory staff will be the primary responsibilities of Associate III.

Responsibilities

• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
• Independently and proactively request documentation required for annual reports, compile, finalize and publish for management's review and subsequent dispatch to the Agency.
• Independently work on supplements, compile and publish for management's review. Take a proactive approach to more complex submissions and contact internal stakeholders (when needed) to gain further insight into any given supplement. Convey findings to management and incorporate any applicable information in the submission to ensure quality and a right first-time submission.
• Assist management and proactively train Associate Is and Associate IIs on guidance, internal processes, procedures, databases and trackers.
• Other projects and duties as required/assigned.
• Process improvement.

Qualifications

• Bachelors in pharmacy/masters in pharmacy/Master in science & Life sciences.
• 7-9 years of experience in the Pharmaceutical Industry: Regulatory, Analytical, QA, laboratory or production experience preferred.
• Minimum 6 years of RA experience will be preferred in the respective Markets.
• Demonstrates an understanding of ICH and FDA guidelines.
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• Demonstrates excellent verbal and written communication skills.
• Demonstrates excellent organizational skills and the ability to multi-task, detail oriented.
• Possesses strong critical and logical thinking.

EEO 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.