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Regulatory Affairs Associate

HYDERABAD (IN)ONSITEPOSTED: 7/22/2026
PHARMAFull-time
HIRING ORGANIZATIONNOVARTISPharmaceuticals / Healthcare
Novartis

ROLE DEFINITION & RESPONSIBILITIES

Novartis is hiring a Regulatory Affairs Associate for its Hyderabad office. This role is ideal for candidates interested in regulatory submissions, dossier preparation, regulatory compliance, clinical trial documentation, and pharmaceutical regulatory affairs. It offers exposure to international regulatory processes, cross-functional collaboration, and global product registrations.

Major Responsibilities

Prepare and coordinate high-quality regulatory submissions.
Support CTA, NDA, and supplementary application submissions.
Maintain regulatory dossiers and submission documentation.
Ensure timely license renewal submissions.
Support CMC documentation and regulatory maintenance.
Manage PSUR and RMP submission activities.
Maintain regulatory databases and archives.
Track regulatory certificates, dossiers, and registration samples.
Communicate with Health Authorities regarding regulatory queries.
Coordinate regulatory documentation across global teams.
Maintain registration master files.
Follow Novartis SOPs and regulatory procedures.
Report product complaints, adverse events, and special case scenarios within required timelines.
Support artwork-related regulatory activities where applicable.

REQUIRED VERIFIED SKILLS

B.Pharm
M.Pharm
Pharm.D
MSc Life Sciences
Regulatory Affairs knowledge
Regulatory Compliance
Dossier preparation
Documentation management

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Although specific compensation figures are not listed, Novartis provides market-leading packages for entry to early-career regulatory professionals in India, including comprehensive benefits and performance incentives.

ORGANIZATION CONTEXT & CULTURE

Novartis AG is a Swiss multinational pharmaceutical corporation, one of the largest in the world. It focuses on discovering, developing, manufacturing, and marketing innovative medicines to address significant health needs. The company's portfolio spans various therapeutic areas including oncology, immunology, neuroscience, and cardiovascular diseases.

TEAM SIZE: 76,000+ employees
INDUSTRY: Pharmaceuticals / Healthcare

EXPECTED CAREER ROADMAP

Joining Novartis as a Regulatory Affairs Associate provides premier exposure to global health authority submissions, lifecycle management, and international regulatory frameworks. Experience in preparing CTAs, NDAs, and managing PSUR/RMP submissions opens clear pathways toward senior regulatory strategist, CMC manager, or global regulatory affairs lead roles.

APPLICATION ADVISORY

Highlight any formal coursework, internships, or practical exposure related to CTD/eCTD dossier structures, CMC documentation, and global health authority guidelines (FDA, EMA, CDSCO). Emphasize precise technical writing skills and familiarity with safety report handling like PSURs and RMPs.
RECOMMENDED TRAINING
1/5
Biologics Regulatory Affairs Certification

Biologics Regulatory Affairs Certification

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.