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Work as Regulatory Affairs Associate Director at Teva

Work as Regulatory Affairs Associate Director at Teva

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.

Post : Associate Director, Regulatory Affairs

Job Description
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:
o Variations and amendments
o Manufacturing and site changes
o Labeling updates
o Safety-related updates
o Renewals and license maintenance activities
o 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

Candidate Profile
• 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


Additional Information
Experience : 5+ years
Qualification : Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Regulatory Affairs
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th December 2026

Assoc Dir Regulatory Affairs Apply Online

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