Assoc Dir Regulatory Affairs

Location: Bengaluru, India

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
The Associate Director, Regulatory Affairs - APAC Lifecycle Management is responsible for leading a team of Regulatory Affairs professionals supporting post-approval and lifecycle management activities across the Asia-Pacific (APAC) region. The role provides strategic and operational leadership for regulatory maintenance activities, ensuring compliance, regulatory excellence, and uninterrupted product supply across a diverse portfolio of innovative medicines, biologics, biosimilars, and/or generic products. The role is expected to partner closely with market RA regulatory affairs, global regulatory, CMC, labeling, safety, supply chain, quality, and commercial stakeholders.
How You’ll Spend Your Day
Leadership & People Management
+ Lead, coach, and develop a team of Regulatory Affairs professionals supporting APAC lifecycle management activities
+ Establish a centralized hub model with clear objectives, performance expectations, and development plans for team members.
+ Foster a culture of accountability, collaboration, innovation, and continuous improvement.
+ Build regulatory capabilities and succession plans across the organization.
+ Drive employee engagement and talent development within the team.
Regulatory Strategy & Execution
+ Develop and oversee regulatory lifecycle strategies across APAC markets, support individual markets as per business need with regulatory submissions.
+ Ensure timely execution of post-approval submissions, including:
+ Variations and amendments
+ Manufacturing and site changes
+ Labeling updates
+ Safety-related updates
+ Renewals and license maintenance activities
+ Product transfers and divestments
+ Assess regulatory risks and develop mitigation strategies.
Portfolio & Compliance Management
+ Ensure continuous regulatory compliance and maintenance of product registrations across APAC markets.
+ Monitor upcoming regulatory commitments, regulatory intelligence, and submission requirements.
+ Maintain inspection readiness and support responses to regulatory agency requests.
+ Ensure robust tracking and management of regulatory commitments, approvals, and implementation requirements.
Cross-Functional Collaboration
+ Partner with Market Regulatory Affairs to ensure alignment of regional and global regulatory strategies.
+ Collaborate with CMC, Quality, Supply Chain, Manufacturing, Pharmacovigilance, and Labeling teams to enable successful product lifecycle changes.
+ Support business continuity and product supply through proactive regulatory planning.
+ Serve as the primary regulatory representative for APAC lifecycle management initiatives for APAC markets.
Operational Excellence
+ Drive standardization, harmonization, and process improvements across APAC regulatory operations to establish the hub model across the team
+ Leverage digital tools and regulatory information management systems to improve efficiency.
+ Monitor team performance using KPIs and business metrics.
+ Lead resource planning and workload prioritization across the APAC portfolio
Your Skills and Experience
+ Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Regulatory Affairs, or related discipline.
+ Advanced degree (MSc, PharmD, MBA, Ph.D or equivalent) preferred
+ 12-15 Years of Regulatory Affairs experience within the pharmaceutical; biotechnology, or related healthcare industry with 7+ years experience in direct people management.
+ Significant experience managing post-approval lifecycle activities across multiple APAC markets.
+ Prior people leadership experience, including management of direct reports and geographically dispersed teams.
+ Experience supporting innovative medicines, biologics, biosimilars, or generics portfolios.
+ Demonstrated success leading complex cross-functional programs.
+ Good leadership, project management and communication skills
+ Excellent analytical, problem-solving, and self-learning skills.
+ Ability to work independently and effectively in a cross-functional team environment; manage multiple projects simultaneously.
+ Detail-oriented with a high level of accuracy in work deliverables.
+ Strong organizational and time management skills.
+ Excellent spoken and written English is essential
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.
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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.
EOE including disability/veteran