ClinChoice, a global clinical research and regulatory services organization, is inviting applications for Associate / Senior Associate – Regulatory Affairs (Drug Listing) and Senior Associate – Regulatory Affairs (Reg Ops EU MDR) positions in Bengaluru, India. These roles are ideal for professionals seeking long-term growth in pharmaceutical and medical device regulatory affairs.
With a presence across the US, UK, Europe, and Asia-Pacific, ClinChoice partners with leading pharmaceutical, biotech, and medical device companies to deliver regulatory excellence, lifecycle management, and patient safety solutions.
🔹 Open Positions at ClinChoice
1) Associate / Senior Associate – Regulatory Affairs (Drug Listing)
Location: Bengaluru, India (Office-based)
Experience: 2–4 Years
Employment Type: Full-time, Permanent
Key Responsibilities
- Execute drug product lifecycle management for North America.
- Prepare and submit FDA regulatory submissions for new launches and changes.
- Write, review, and submit Drug Listing (DL) documentation.
- Evaluate and maintain NDC numbers for bulk and finished products.
- Manage change controls and regulatory impact assessments.
- Ensure compliance, accuracy, and on-time submissions.
- Maintain documents in CEDMS, DSP/cMAT, Reg Point, and SharePoint.
- Support Annual Product Registration and Establishment Registration.
Qualifications
- Bachelor’s degree in Pharmacy/Life Sciences or related field.
- 2–4 years of experience in Regulatory Affairs, QA, Labelling, or Packaging.
- Hands-on experience with FDA submissions and drug listing activities.
- Knowledge of NDC assignment and regulatory documentation systems.
- Strong organizational and communication skills.
2) Senior Associate – Regulatory Affairs (Reg Ops EU MDR)
Location: Bengaluru, India (Remote)
Experience: 4–6 Years
Employment Type: Full-time
Key Responsibilities
- Compile and maintain Technical File / Design Dossier under EU MDR 2017/745.
- Identify applicable standards, MDCG guidance, and regulatory requirements.
- Perform QC checks on regulatory documents (pagination, completeness, accuracy).
- Create and upload indexed PDF files into PLM systems via Change Orders.
- Coordinate with affiliates for legal documents (CFS, CFG, etc.).
- Represent Regulatory Affairs on cross-functional project teams.
- Communicate project status and deliverables to management.
Qualifications
- Bachelor’s degree (Life Sciences preferred).
- 4–6 years experience in EU MDR Regulatory Operations.
- Strong knowledge of EU MDR, ISO 13485, and FDA medical device regulations.
- Excellent English communication and MS Office proficiency.
💼 Why Join ClinChoice?
- Global exposure to pharmaceutical and medical device projects.
- Career growth in Regulatory Affairs and Regulatory Operations.
- Flexible work options (remote role available).
- Competitive salary and benefits.
- Work with international clients and cutting-edge regulatory platforms.
📩 How to Apply
Application Link For Senior Associate – Regulatory Affairs (Reg Ops EU MDR)
Application Link For Associate / Senior Associate – Regulatory Affairs (Drug Listing)
