Regulatory Affairs Specialist II

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 Responsible for managing and executing regulatory registration activities across the product lifecycle, including submission, follow-up, and liaison as needed with Health Authorities across International Markets (IM). Provides regulatory expertise, ensures timely responses to authority queries, and maintains accurate regulatory documentation and systems in compliance with GxP requirements.

How You’ll Spend Your Day Regulatory Submissions

• Manage and support Life Cycle Management activities related to Branded/Specialty and Generic products in IM region in close collaboration with assigned market regulatory team. This includes variations, renewals, response to HA queries, labeling activities etc.
• Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Ensure assigned training is completed on a timely manner and documented before performing a GxP activity, either in Studium or in paper training record form.
• Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc) and support AI initiatives as assigned.
• Work closely with market RA in International Markets to complete all assigned activities

Your Skills and Experience

• B. Pharm / M. Pharm (preferred) with 1 year experience in regulatory affairs or related R&D area focusing on compliance activities.
• MS Office (Word, Excel, Powerpoint, Outlook) proficiency

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.

Already Working @Teva? Make sure to apply through our internal career site on Twist—your one-stop shop for career development

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.