Mgr Regulatory Affairs

## 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

- Management of the submission and approval process for Teva products International Markets (IM) to support business opportunities for the company.
- Management of regulatory compliance including product life cycle maintenance (Variations, renewal, etc), data sheets, labelling, regulatory compliance files and regulatory databases.
- Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.

How You’ll Spend Your Day

Regulatory Submissions

- Manage all submissions and maintenance 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.  Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.
- Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)
- Drive data and digital initiatives as per organizational goals and look for opportunities to increase efficiency of regulatory workload/process via automation opportunities

Regulatory Intelligence/Expertise/Guidance/Education

- Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities
- Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by
- providing impact analysis feedback to commercial teams.
- Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.
- Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.
- Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.
- Work closely with market RA in International Market RA Regions to complete all assigned activities

## Your Skills and Experience

- B. Pharm / M. Pharm (preferred) with 10+ years of experience, regulatory experience in CMC variations, labeling and life cycle management.
- Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.
- Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (International Markets Preferred).

## 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.