ClinChoice Regulatory Affairs Drug Listing Jobs in Bengaluru
- Company Overview
- Job Role & Responsibilities
- Primary Responsibilities
- Secondary Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Frequently Asked Questions
- Is this role suitable for freshers?
- Which region does this role primarily support?
- Is experience with NDC mandatory?
- Is this a permanent role?
- Are there growth opportunities?
Regulatory Affairs Vacancies – Bengaluru
BPharm/MPharm candidates required for Associate/Senior Associate Regulatory Affairs Drug Listing roles in Bengaluru.
Regulatory Affairs professionals with hands-on experience in drug listing and FDA submissions are increasingly in demand as pharmaceutical companies expand and optimize product lifecycle management in regulated markets. ClinChoice is currently hiring Associate and Senior Associate – Regulatory Affairs (Drug Listing) professionals for its Bengaluru office. This role is ideal for experienced regulatory professionals who want to work closely with US regulatory frameworks while contributing directly to compliant drug commercialization and lifecycle activities.
Company Overview
ClinChoice is a global clinical research and regulatory services organization established in 1995. The company partners with leading pharmaceutical, biotechnology, medical device, and consumer healthcare organizations to accelerate clinical development, product registration, and patient safety initiatives.
With expertise spanning clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology, ClinChoice supports clients across the full product lifecycle. Its global delivery network includes offices and delivery centers in the United States, United Kingdom, Mexico, Armenia, China, Japan, India, and the Philippines, enabling localized regulatory compliance with global oversight.
ClinChoice is recognized for its data-driven approach, regulatory precision, and ability to deliver high-quality submissions that meet stringent global health authority requirements.
Job Role & Responsibilities
The Associate / Senior Associate – Regulatory Affairs (Drug Listing) role is a full-time, office-based position focused on US drug listing activities, FDA submissions, and lifecycle management for pharmaceutical products.
Primary Responsibilities
• Execute drug product lifecycle management activities for the North America region
• Prepare, compile, coordinate, and submit FDA regulatory submissions for new product launches and post-approval changes
• Author, review, and submit Drug Listing (DL) documentation in compliance with FDA requirements
• Evaluate, assign, and maintain National Drug Code (NDC) numbers for bulk and finished dosage products
• Review, approve, and manage change controls with regulatory impact related to drug listing
• Ensure submission accuracy, regulatory compliance, and adherence to defined timelines
Secondary Responsibilities
• Upload, route, and maintain regulatory documentation in electronic systems such as CEDMS, DSP/cMAT, RegPoint, and SharePoint
• Update controlled documents including SOPs, CAPAs, investigations, and corrections within electronic document management systems
• Support annual product registration and FDA establishment registration activities
• Track change control deliverables, manage timelines, and initiate extensions when required
• Communicate project status, milestones, risks, and dependencies to internal and external stakeholders
• Act as project lead when required by coordinating cross-functional meetings to ensure on-time drug listing completion
This role offers deep exposure to US FDA drug listing processes, regulatory documentation systems, and lifecycle management strategies.
Eligibility / Qualifications
This position is suited for regulatory professionals with experience in FDA submissions and drug listing activities.
Required qualifications:
• 2–4 years of experience in Regulatory Affairs, Quality Assurance, Packaging, or Labelling
• Hands-on experience with FDA submissions and drug listing activities
• Working knowledge of NDC assignment processes and FDA regulatory requirements
• Experience with regulatory document management systems
• Strong organizational skills with high attention to detail and compliance
• Ability to manage multiple timelines and coordinate cross-functional activities
• Effective written and verbal communication skills
Relevant educational background includes:
BPharm, MPharm, Pharmaceutics, Pharmaceutical Regulatory Affairs, Industrial Pharmacy, Pharmaceutical Sciences
Location & Salary
Job Location: Bengaluru, Karnataka
This is a full-time, permanent, office-based position in Bengaluru. Salary details are not publicly disclosed; however, ClinChoice offers competitive compensation packages aligned with regulatory affairs roles in the pharmaceutical and CRO industries.
Application Process
Interested candidates can apply directly through the official ClinChoice careers portal using the link below:
Apply Online: https://job-boards.eu.greenhouse.io/clinchoice/jobs/4774309101?source=LI
Frequently Asked Questions
Is this role suitable for freshers?
No. This role requires prior experience in regulatory affairs and FDA drug listing activities.
Which region does this role primarily support?
The role primarily supports North America and US FDA regulatory requirements.
Is experience with NDC mandatory?
Yes. Knowledge of NDC assignment and maintenance is a key requirement for this role.
Is this a permanent role?
Yes. This is a full-time permanent position.
Are there growth opportunities?
Yes. Professionals can progress into senior regulatory affairs, regulatory strategy, and global compliance roles.
| Category | Details |
|---|---|
| Company | ClinChoice |
| Vacancies | Associate / Senior Associate – Regulatory Affairs (Drug Listing) |
| Required Education | BPharm, MPharm, Pharmaceutical Sciences |
| Experience | 2–4 Years |
To apply for this job please visit job-boards.eu.greenhouse.io.
