Regulatory Analyst - Clinical Affairs

Position Overview

We are seeking a highly motivated and detail-oriented Regulatory Medical Writer to join our team. The ideal candidate will have experience in creating clinical regulatory documents for the Central Drugs Standard Control Organization (CDSCO), the EU Medical Device Regulation (MDR), and other regulatory bodies. The Regulatory Medical Writer will play a crucial role in developing key documents such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) Reports, and other regulatory submissions.

• Collaborate with cross-functional teams to gather and analyze clinical data for inclusion in regulatory submissions.
• Develop and maintain expertise in CDSCO, EU MDR regulations, and other regulatory guidelines, and standards related to clinical evaluations and post-market surveillance.
• Draft, review, and edit Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) Reports, and other regulatory documents as required.
• Ensure accuracy, completeness, and compliance of regulatory documents with applicable regulations and guidelines.
• Provide support during regulatory inspections and audits, as needed.
• Stay informed about changes in regulatory requirements and guidelines and communicate implications to relevant stakeholders.

• Bachelor's degree in a relevant scientific or technical discipline. An advanced degree is preferred.
• At least 2-3 years of experience in regulatory medical writing within the pharmaceutical, biotechnology, or medical device industry.
• Should be proficient in literature search engines like Pub Med, Cochrane, etc., and capable of extracting relevant clinical studies for documentation.
• Experience with creating clinical regulatory documents for CDSCO and EU MDR is preferred.
• Strong understanding of regulatory requirements and guidelines governing clinical evaluations and post-market surveillance.
• Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and effectively.
• Detail-oriented with strong organizational and time management skills.
• Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.