Associate / Senior Associate – Regulatory Affairs (Drug Listing)

Job Title: Associate / Senior Associate – Regulatory Affairs (Drug Listing)
Employment Type: Full-time (Permanent)
Location: Bengaluru, India
Work Type: Office-based

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Primary Responsibilities
•    Execute drug product lifecycle management activities for the North America region.
•    Prepare, compile, coordinate, and submit FDA regulatory submissions for new launches, updates, and lifecycle management activities.
•    Write, review, and submit Drug Listing (DL) documentation.
•    Evaluate, assign, and maintain NDC numbers for bulk and finished products in compliance with SOPs and regulations.
•    Review, approve, and manage change controls related to drug listing and regulatory impact.
•    Ensure regulatory compliance, submission accuracy, and adherence to defined timelines.

Secondary Responsibilities
•    Upload, route, and maintain regulatory documentation in internal systems (CEDMS, DSP/cMAT, Reg Point, SharePoint).
•    Update controlled documents such as SOPs, Investigations, CAPAs, and Corrections in electronic systems.
•    Support Annual Product Registration and Establishment Registration activities.
•    Track change control deliverables, ensure timely closure, and initiate extensions when required.
•    Communicate project status, milestones, and risks to stakeholders.
•    Act as a project lead when required by coordinating meetings to support on-time Drug Listing completion.

Candidate’s Profile
•    2–4 years of experience in Regulatory Affairs, Quality Assurance, Packaging, or Labelling.
•    Experience with FDA submissions, drug listing activities, and regulatory documentation.
•    Knowledge of NDC assignment processes and regulatory compliance requirements.
•    Familiarity with regulatory document management systems.
•    Strong organizational skills with attention to detail and compliance.
•    Ability to manage timelines, coordinate cross-functional activities, and communicate effectively.