Regulatory Affairs Associate II

Teva; Navi Mumbai; On-site; INR 1,000,000 - 1,400,000; Full time

Job summary

Teva India is seeking an Associate II in Regulatory Affairs/Quality Assurance to prepare, review and submit high quality regulatory submissions to the FDA within timelines and guidelines. The role involves evaluating change controls, maintaining regulatory databases, and supporting annual reports and post-approval submissions.

The position requires a 4+ year background in pharma regulatory/QA and the ability to work independently within a collaborative team.

Qualifications

• M. Pharma degree in RA/QA discipline, a plus.
• Minimum 4+ years 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 on teams
• Good verbal and written communication skills
• Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

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 managements review.
• Under management’s direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement 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.
• When needed, train Associate I’s on internal processes, procedures, databases and trackers.
• Other projects and duties as required/assigned

Skills

M.Pharm RA/QA

Regulatory experience

Analytical QA experience

Documentation skills

Communication skills

Education

M.Pharm in RA/QA

Tools

MS Word

Excel

Internet skills

Job description

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

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), will assure 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 the Associate II.

How You’ll Spend Your Day

• 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 managements review.
• Under management’s direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement 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.
• When needed, train Associate I’s on internal processes, procedures, databases and trackers.
• Other projects and duties as required/assigned

Your Skills and Experience

• M. Pharma degree in RA/QA discipline, a plus.
• Minimum 4+ years 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 on teams
• Good verbal and written communication skills
• Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

How We’ll Take Care of You

At Teva India, care is at the heart of how we work. From your first day, you’ll be welcomed into a people-first culture built on inclusion, respect, and belonging.

That support extends to you and your loved ones through benefits designed for real life. These include comprehensive medical insurance, OPD coverage, annual health checkups, term life and accident insurance, and confidential emotional wellbeing support through our Optum Employee Assistance Program. You’ll also enjoy healthy meals at work, holistic wellbeing initiatives, and volunteering programs that help you give back to the community.

Your growth matters too. You’ll have opportunities to build future-ready skills, collaborate on projects with global teams, explore internal career opportunities, and learn through programs such as our AI-enabled Teva Twist program, R&D Academy, continuing education, and mentorship.

Join our vibrant workplace, where we celebrate milestones, festivals, achievements, and community impact together.

Teva’s Equal Employment Opportunity 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.