Regulatory Affairs Specialist II

Teva; Karnataka; Vor Ort; INR 700.000 - 1.100.000; Vollzeit

Benefits dieser Stelle

Medical insurance

OPD coverage

Life and accident insurance

Wellbeing programs

Meals at work

Career development opportunities

Mentorship

Zusammenfassung

Teva India is seeking a Regulatory Affairs professional to manage and execute regulatory submissions, life-cycle activities, and labeling changes for branded, generic, and specialty products in International Markets. You will ensure compliance with local regulations and collaborate with global RA teams to address authority queries.

The role requires a B.Pharm / M.Pharm with ~1 year in regulatory affairs or related R&D, and proficiency in MS Office.

Qualifikationen

• B.Pharm or M.Pharm degree with 1 year experience in regulatory affairs or related R&D focusing on compliance activities.
• MS Office proficiency (Word, Excel, PowerPoint, Outlook) is required.

Aufgaben

• Regulatory submissions and lifecycle management for IM region products in close collaboration with market regulatory teams.
• Coordinate variations, renewals, and responses to health authority queries.
• Maintain regulatory documentation and systems in compliance with GxP requirements.

Kenntnisse

Regulatory affairs

Compliance

MS Office

Ausbildung

B.Pharm / M.Pharm

Tools

GRIDS

GI Insights

Teva Art

Veeva

Jobbeschreibung

We Are TevaWe’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 ImpactResponsible 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 DayRegulatory SubmissionsManage 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 activitiesYour Skills and ExperienceB. 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) proficiencyHow We’ll Take Care of YouAt 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 developmentTeva’s Equal Employment Opportunity CommitmentTeva 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.