Job Title: Associate Director, Complex Gx, Regulatory Affairs
Date Posted: Sep 4, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job ID: 63163
Company Overview:
Teva Pharmaceuticals is committed to making good health more affordable and accessible worldwide. Operating in nearly 60 countries, Teva is a leading manufacturer of generic medicines and a producer of many products on the WHO Essential Medicines List. Over 200 million people take Teva medicines daily.
Opportunity Overview:
The Associate Director, Complex Gx, Regulatory Affairs serves as a strategic regulatory leader for U.S. FDA-regulated semi-solid, transdermal, and nasal spray complex generic products. The role ensures regulatory compliance, operational excellence, and leadership of a regulatory team to deliver high-quality submissions and lifecycle management. This role acts as a key liaison with the FDA, internal cross-functional teams, and external partners, driving early engagement to mitigate regulatory risk and accelerate time-to-market.
Key Responsibilities:
Regulatory Leadership & Strategy:
Provide oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products.
Develop and implement regulatory strategies aligned with business objectives.
Drive early FDA engagement to reduce regulatory risk and support first-cycle approvals.
Represent Regulatory Affairs in global and regional forums for strategic planning and alignment.
Team Leadership & Development:
Mentor and develop regulatory staff, supporting succession planning.
Lead departmental planning, resource management, and policy development.
Foster a culture of transparency, open communication, and continuous improvement.
Regulatory Compliance & Submission Management:
Ensure submission documents are accurate, complete, and FDA-compliant.
Lead regulatory assessments for site transfers, formulation modifications, and alternate API sourcing.
Oversee regulatory documentation systems ensuring data integrity.
Cross-Functional Collaboration:
Collaborate with R&D, QA, Manufacturing, and other teams to resolve regulatory challenges.
Support internal and external audits and FDA inspections.
Build and maintain strong relationships with FDA project managers and external partners.
Operational Excellence & Monitoring:
Monitor and optimize KPIs, submission timelines, and team development goals.
Manage departmental budgets related to regulatory submissions and administrative operations.
Identify and cultivate new opportunities aligned with organizational goals.
Experience & Qualifications:
Education:
Bachelor’s or Master’s degree (preferred) in Pharmacy, Life Sciences, or related fields (M.Sc., Ph.D.).
Experience:
Minimum 12+ years in the pharmaceutical industry, including 8+ years in U.S. Regulatory Affairs for complex generic drug products.
At least 6 years of leadership experience managing regulatory teams and product portfolios.
Skills & Competencies:
In-depth knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
Proficiency with regulatory systems (Veeva, TrackWise) and document management platforms (Wisdom, Glorya, Livelink, Knowledgetree).
Strong FDA interaction experience with negotiation and influencing skills.
Excellent verbal and written communication.
Experience in matrixed, multinational environments and with third-party partners.
Lean Six Sigma or equivalent process improvement training is a plus.
Internal Applicants:
Current Teva employees should apply via the internal career site "Employee Central" for priority consideration.
Equal Employment Opportunity:
Teva Pharmaceuticals is committed to equal employment opportunity and provides accommodations during recruitment and selection upon request.
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