Associate Director – Regulatory Affairs (Fresher / Entry-Level Opportunity)
Location: Bangalore, India – 560064
Category: Regulatory Affairs / Pharmaceutical Compliance / FDA Submissions
Job Type: Full-Time
Experience Required: Fresher / 0–2 Years
Job ID: 63163
Company Overview
Teva Pharmaceuticals is a global pharmaceutical leader dedicated to improving healthcare accessibility and affordability. Operating in nearly 60 countries, Teva is recognized for generic and specialty medicines, many of which are included on the World Health Organization’s Essential Medicines List. Over 200 million patients worldwide rely on Teva products daily.
This role provides an excellent opportunity for freshers to start a career in regulatory affairs, gaining exposure to FDA regulations, drug development, and complex generic product lifecycle management in a global pharmaceutical environment.
Role Overview
The Associate Director – Regulatory Affairs supports regulatory activities for complex generic products, including semi-solid, transdermal, and nasal spray formulations. This entry-level role allows freshers to learn regulatory compliance, FDA submission processes, and lifecycle management, working under guidance from experienced regulatory professionals.
The position provides hands-on experience in document preparation, compliance monitoring, and cross-functional collaboration, preparing candidates for a long-term career in pharmaceutical regulatory affairs.
Key Responsibilities
Support regulatory submission preparation for U.S. FDA-regulated complex generic products, including pre- and post-approval activities.
Assist in early engagement with the FDA under the guidance of senior colleagues to streamline regulatory pathways.
Contribute to regulatory assessments, including formulation changes, site transfers, and alternative API sourcing.
Ensure submission documents comply with FDA regulations and internal SOPs, supporting a Right-First-Time approach.
Collaborate with cross-functional teams (R&D, QA, Manufacturing) to resolve regulatory challenges.
Support maintenance of regulatory documentation systems, ensuring data integrity and accuracy.
Participate in training and development programs to understand FDA regulations, eCTD submissions, and global regulatory standards.
Monitor regulatory updates and guidance to ensure compliance and informed decision-making.
Assist in preparation for internal and external audits and inspections as required.
Qualifications & Skills
Education:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field (M.Sc., PharmD, or Ph.D.). Fresh graduates are encouraged to apply.
Experience:
Fresher / 0–2 years of exposure to pharmaceutical regulatory affairs, R&D, or quality assurance.
Academic or internship experience in regulatory documentation or clinical research is a plus.
Skills:
Basic understanding of FDA regulations, ICH guidelines, and pharmaceutical drug development processes.
Familiarity with electronic document management systems and Office 365 applications.
Strong organizational, analytical, and communication skills.
Ability to work collaboratively in cross-functional and global teams.
Why Join Teva Pharmaceuticals?
Launch your career in pharmaceutical regulatory affairs with hands-on exposure to complex generic product submissions.
Learn from global experts and gain experience in FDA compliance, regulatory strategy, and lifecycle management.
Opportunity to work in a dynamic, multinational environment with structured mentorship and growth pathways.
Equal Employment Opportunity
Teva Pharmaceuticals is committed to a diverse and inclusive workplace. Employment decisions are made without regard to age, race, color, religion, sex, disability, sexual orientation, gender identity, veteran status, or any other legally protected status. Accommodations are provided for candidates requiring support during the recruitment process.
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