Associate / Senior Associate Regulatory Affairs (Drug Listing)

Roles & Responsibilities
• Execute drug product lifecycle management activities for the North America region
• Prepare, compile, coordinate, and submit FDA regulatory submissions for new product launches, updates, and lifecycle management activities
• Write, review, and submit Drug Listing (DL) documentation in compliance with FDA regulations
• Evaluate, assign, and maintain National Drug Code (NDC) numbers for bulk and finished products as per SOPs and regulatory requirements
• Review, approve, and manage change controls impacting drug listing and regulatory submissions
• Ensure regulatory compliance, submission accuracy, and adherence to defined timelines
• Upload, route, and maintain regulatory documentation in systems such as CEDMS, DSP/cMAT, Reg Point, and SharePoint
• Update controlled documents including SOPs, Investigations, CAPAs, and Corrections in electronic document management 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, risks, and deliverables to internal stakeholders
• Act as project lead when required by coordinating meetings to ensure on-time Drug Listing completion

Qualifications
• Bachelor’s degree in Pharmacy, Life Sciences, or related discipline

Experience
• 2–4 years of experience in Regulatory Affairs, Quality Assurance, Packaging, or Labelling

Skills
• Hands-on experience with FDA submissions and Drug Listing activities
• Strong knowledge of NDC assignment processes and regulatory compliance requirements
• Familiarity with regulatory document management systems
• Excellent organizational and documentation skills with strong attention to detail
• Ability to manage timelines and coordinate cross-functional teams
• Strong verbal and written communication skills

About the Organization
ClinChoice is a global regulatory, clinical, and biometrics services partner supporting leading pharmaceutical, medical device, and consumer health companies. With a strong global presence and deep regulatory expertise, ClinChoice offers a collaborative work environment, exposure to global regulatory projects, and long-term career growth opportunities.