Regulatory Affairs Associate III

Teva Pharmaceuticals; Bengaluru; Sur place; INR 1 800 000 - 2 400 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Life and accident insurance

Mental health support

Meals at work

Wellbeing programs

Volunteering opportunities

Résumé du poste

Teva India is seeking a senior Regulatory Affairs professional to independently lead post‑approval activities across Global markets. You will drive lifecycle management, handle variations, respond to health authority queries, and ensure compliance with ICH guidelines in a fast‑paced, globally connected environment.

You will work closely with global teams, manage stakeholders, and contribute to strategic regulatory planning while maintaining high standards of quality and timelines.

Qualifications

• Graduation/ Post graduation in Science/ Pharma discipline.
• Minimum 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.

Responsabilités

• Lead, drive and execute regulatory affairs activities for assigned projects.
• Ensure compliance with global regulatory requirements and timelines.
• Interact with international stakeholders across US, EU, APAC and LATAM markets.
• Provide strategic insights and risk/benefit analyses for submissions.
• Collaborate with cross‑functional teams to implement regulatory strategies.
• Manage approvals, variations and post‑approval lifecycle activities.

Connaissances

Regulatory leadership

Post‑approval lifecycle

ICH guidelines

Global regulatory affairs

Stakeholder management

Communication skills

Planning & organization

Formation

Science/Pharma degree

Outils

Regulatory submission tools

Description du poste

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.

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 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 Day

• 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.
• 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 deadlines

Your Skills And Experience

• Graduation/ Post graduation in Science/ Pharma discipline
• Minimum 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 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.