Manager – Regulatory Affairs, Labeling (Fresher / Early-Career Friendly)
Location: Bangalore, India – 400706
Category: Regulatory Affairs / US Generic Labeling / Pharmaceutical Compliance
Job Type: Full-Time
Experience Required: Fresher / 0–2 Years
Job ID: 61891
Company Overview
Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to making healthcare more affordable and accessible. Operating across nearly 60 countries, Teva serves over 200 million patients daily and produces several medicines listed on the World Health Organization’s Essential Medicines List.
Joining Teva provides early-career professionals the opportunity to gain exposure to US regulatory affairs, ANDA/505(b)(2) filings, and structured product labeling (SPL), while contributing to high-impact projects in a collaborative, global environment.
Position Overview
Teva Pharmaceuticals is seeking a Manager – Regulatory Affairs, Labeling to support US generic product labeling operations. This entry-level opportunity is ideal for freshers or early-career candidates with a scientific or regulatory background seeking experience in FDA regulatory compliance and pharmaceutical labeling.
The role involves assisting with the preparation, review, and maintenance of US ANDA/505(b)(2) labeling documents, including SPL, PADERs, and AR compilations, while learning to adhere to FDA regulations, internal SOPs, and company standards.
Key Responsibilities
Assist in developing and implementing US generic labeling strategies across pre- and post-approval stages.
Support FDA reporting obligations and ensure compliance with regulatory requirements.
Contribute to the preparation, review, and electronic compilation of labeling documents, aligning with reference listed drug (RLD) guidance and safety updates.
Learn to maintain labeling trackers, ensuring all projects are on schedule.
Support cross-functional collaboration with Regulatory Operations and other internal departments for timely submission of labeling content in eCTD format.
Gain hands-on experience with structured product labeling (SPL) and related US regulatory guidelines.
Participate in team meetings, SOP/WI creation, and training initiatives as assigned.
Develop awareness of US regulations, guidelines, and best practices applicable to pharmaceutical labeling.
Qualifications & Experience
Educational Requirements:
MPharm/BPharm with a scientific or regulatory background, or equivalent education.
Experience:
Fresher / 0–2 years experience in pharmaceutical regulatory affairs is welcome.
Exposure to US generic labeling, ANDA/505(b)(2) processes, or structured product labeling is a plus.
Skills & Competencies:
Strong interest in pharmaceutical regulatory affairs and US labeling regulations.
Basic understanding of regulatory documentation and compliance requirements.
Excellent organizational, analytical, and communication skills.
Ability to work collaboratively in a cross-functional and global team environment.
Eagerness to learn and apply regulatory guidelines in practical scenarios.
Why Join Teva?
Gain hands-on experience in US regulatory affairs and pharmaceutical labeling.
Work in a collaborative, global environment with exposure to ANDA/505(b)(2) filings.
Build expertise in structured product labeling (SPL) and FDA compliance.
Launch your regulatory career with a globally recognized pharmaceutical company.
Equal Employment Opportunity
Teva Pharmaceuticals is committed to providing equal employment opportunities for all. 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. Reasonable accommodations are available for candidates requiring support during the recruitment process.
Apply Today: Start your career in Regulatory Affairs – US Labeling with Teva Pharmaceuticals, gaining valuable experience in compliance, labeling, and global pharmaceutical operations.
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