Assoc Dir Regulatory Affairs

Teva Pharmaceuticals

12+ years

Not Disclosed

Bangalore

10 Sept. 22, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Associate Director – Regulatory Affairs (Complex Gx)

Date Posted:

4 Sept 2025

Location:

Bangalore, India, 560064

Company:

Teva Pharmaceuticals

Job ID:

63163

Company Overview:

Teva Pharmaceuticals is a global leader in generic, innovative, and biosimilar medicines, committed to making healthcare more affordable and accessible. Teva operates across nearly 60 countries and is a trusted producer of many products on the WHO Essential Medicines List.

Role Overview:

The Associate Director – Complex Gx, Regulatory Affairs serves as a strategic regulatory leader, guiding and executing all regulatory activities—pre- and post-approval—for U.S. FDA-regulated semi-solid, transdermal, and nasal spray complex generic products. This role ensures regulatory compliance, drives operational excellence, leads a team of regulatory professionals, and acts as a key liaison with the FDA, internal cross-functional teams, and external partners.

Key Responsibilities:

Regulatory Strategy & Submissions:

Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products.
Drive early FDA engagement to align development strategy, reduce regulatory risk, and support first-cycle approvals.
Lead regulatory assessments for significant changes, including site transfers, formulation modifications, and alternate API sourcing.
Ensure submission documents are accurate, complete, and FDA-compliant, promoting a Right-First-Time approach.

Team Leadership & Development:

Mentor and develop regulatory staff, supporting leadership growth and succession planning.
Foster a culture of transparency and open communication across all organizational levels.
Lead departmental planning, resource management, and policy development.

Cross-functional Collaboration:

Collaborate with R&D, QA, Manufacturing, and other teams to resolve regulatory challenges.
Represent Regulatory Affairs in global and regional forums, contributing to strategic planning.
Build and maintain strong working relationships with FDA project managers and external partners.

Compliance & Quality Management:

Interpret and apply FDA regulations, ICH guidelines, and eCTD submission standards.
Oversee regulatory documentation systems to ensure data integrity and consistency.
Support internal/external audits and regulatory inspections as required.
Monitor and optimize KPIs, including submission timelines, quality metrics, and team development goals.

Continuous Improvement & Operational Excellence:

Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
Identify and cultivate opportunities aligned with organizational goals.
Manage departmental budgets related to regulatory submissions and administrative operations.

Experience and Qualifications:

Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field (M.Sc., Ph.D. preferred).
Experience:
- 12+ years in pharmaceutical industry.
- 8+ years in U.S. Regulatory Affairs for complex generic products (semi-solid, transdermal, nasal spray).
- 6+ years leadership experience managing regulatory teams and product portfolios.
Skills & Knowledge:
- 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 verbal and written communication skills.
- Experience working 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 on “Employee Central” for priority consideration and access to internal-only opportunities.

Equal Opportunity Statement:

Teva Pharmaceuticals is committed to equal employment opportunity. Employment decisions are based on merit, qualifications, and business requirements without regard to age, race, creed, color, religion, sex, disability, sexual orientation, gender identity, or other legally protected status. Reasonable accommodations are provided to support candidates during the recruitment process.

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Assoc Dir Regulatory Affairs

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