Regulatory Affairs Associate III

Teva; Karnataka; On-site; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Medical insurance

OPD coverage

Health checkups

Term life insurance

Accident insurance

EAP program

Meals at work

Wellbeing initiatives

Volunteer programs

Job summary

Teva India seeks an experienced Regulatory Affairs professional to independently lead and execute post-approval regulatory activities for Generics and Innovative Medicines across US, EU, APAC and LATAM markets.

You will manage renewals, variations, and responses to regulatory authority queries, collaborating with global teams. Strong communication and stakeholder management are essential to succeed in this role.

Qualifications

• Hands-on experience in post-approval life cycle management activities including renewals, variations (CMC, labeling etc), response to HA queries for assigned Generics/Innovative Medicines portfolio for International Markets Regulatory Affairs.
• Solid understanding of ICH and regulatory guidelines for US, EU, APAC, LATAM, and other ROW markets.
• Excellent internal and external communication skills and strong collaboration abilities at local and regional levels.

Responsibilities

• Responsible for independently leading, driving and executing all the Regulatory Affairs activities independently for assigned projects, ensuring compliance with global regulatory requirements.
• Ability to work independently and effectively in a global environment with strong communication skills.
• Capacity to integrate both the big picture and detailed analysis.

Skills

Regulatory affairs

Post-approval lifecycle mgmt

Global regulatory requirements

Stakeholder management

ICH guidelines

Communication skills

Project planning

Education

Graduation/ Post graduation in Science/ Pharma

B.Pharm / M.Pharm / MSc

Job description

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 independently leading, driving and executing all the Regulatory Affairs activities independently for assigned projects, ensuring compliance with global regulatory requirements.How You’ll Spend Your DayHands-on experience in post-approval life cycle management activities including renewals, variations (CMC, labeling etc), response to HA queries for assigned Generics/Innovative Medicines portfolio for International Markets Regulatory Affairs.Ability to work independently and effectively in a global environment with strong communication skills.Solid understanding of ICH and regulatory guidelines for US, EU, APAC, LATAM, and other ROW markets.Capacity to integrate both the big picture and detailed analysis.Strategic thinking with flexibility to adapt to changes.Excellent internal and external communication skills (written and oral) and strong collaboration abilities at local and regional levels.Ability to share concepts, ideas, information, and suggestions with management, peers, and other stakeholders.Strong risk/benefit analysis skills.Proven ability to establish and maintain good working relationships at all levels within the company and with external stakeholders (stakeholder management).Effective planning and organizational skills.Ability to multi-task, remain detail-oriented, and work under pressure to meet tight deadlinesYour Skills and ExperienceGraduation/ Post graduation in Science/ Pharma disciplineMinimum 6+ Yrs (for post-graduates)/ 8+ Yrs (for graduates) in core post-approval regulatory activity in US, EU and other international markets for Generics/Innovative Medicines.How 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.