Regulatory Affairs Associate / Senior Associate Job At ClinChoice
ClinChoice is hiring an Associate / Senior Associate – Regulatory Affairs (Drug Listing) in Bengaluru. This Regulatory Affairs Job will drive compliance and regulatory excellence by managing FDA submissions, drug listing documentation, and product lifecycle activities for global pharmaceutical products. Graduates seeking Pharma Jobs or Pharmacy jobs can apply now.
- Job Title: Associate / Senior Associate – Regulatory Affairs (Drug Listing)
- Location: Bengaluru, India
About the Company
ClinChoice is a global partner to leading pharmaceutical, medical device, and consumer care innovators, providing expertise in clinical operations, regulatory affairs, pharmacovigilance, medical affairs, and toxicology. Established in 1995, ClinChoice leverages data-driven insights and cutting-edge solutions to help clients maintain regulatory compliance worldwide.
Key Responsibilities
- Execute drug product lifecycle management activities for North America.
- Prepare, compile, coordinate, and submit FDA regulatory submissions for new launches, updates, and lifecycle management.
- Write, review, and submit Drug Listing (DL) documentation.
- Evaluate, assign, and maintain NDC numbers for bulk and finished products.
- Review, approve, and manage change controls related to drug listing and regulatory impact.
- Ensure regulatory compliance, submission accuracy, and adherence to timelines.
- Upload, route, and maintain regulatory documentation in internal systems (CEDMS, DSP/cMAT, Reg Point, SharePoint).
- Update controlled documents, SOPs, investigations, CAPAs, and corrections.
- Support Annual Product Registration and Establishment Registration activities.
- Track change control deliverables and initiate extensions when needed.
- Communicate project status, milestones, and risks to stakeholders.
- Act as project lead when required to ensure timely Drug Listing completion.
Educational Qualification
- 2–4 years of experience in Regulatory Affairs, Quality Assurance, Packaging, or Labelling.
- Experience with FDA submissions, drug listing activities, and regulatory documentation.
Skills Required
- Knowledge of NDC assignment processes and regulatory compliance requirements.
- Familiarity with regulatory document management systems.
- Strong organizational skills, attention to detail, and compliance.
- Ability to manage timelines, coordinate cross-functional activities, and communicate effectively.
Why This Job Role?
This Regulatory Affairs Job role provides an opportunity to work with a leading global regulatory affairs team to ensure pharmaceutical compliance and support product lifecycle management. Gain hands-on experience in FDA submissions and regulatory documentation while contributing to global patient safety and healthcare delivery. Graduates seeking Pharma Jobs or Pharmacy jobs can apply now.
