Job Description

Drug Regulatory Affairs Specialist Responsibilities & Duties

Develop and implement regulatory strategies to bring drugs to market in compliance with relevant laws and regulations. Conduct regulatory research and provide guidance on regulatory issues and requirements. Prepare and submit applications and regulatory submissions, such as INDs, NDAs, and BLAs. Communicate with regulatory agencies and respond to inquiries. Manage projects and timelines to ensure timely submission of regulatory documents. Work with cross-functional teams to ensure regulatory compliance throughout the product development process. Stay informed of regulatory changes and trends in the industry.

Drug Regulatory Affairs Specialist Qualifications & Skills

degree in pharmacy, life sciences, or a related field. Professional certification in regulatory affairs (e.g., RAC). Familiarity with electronic submission standards (eCTD). Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). Strong project management skills. Proven ability to work in a fast-paced, deadline-driven environment. Bachelor's or Master's degree in a relevant field, such as pharmaceuticals, biology, or chemistry. Strong knowledge of FDA regulations and processes. Excellent project management skills. Excellent written and verbal communication skills. Ability to work well in a team environment.
Job Types: Full-time, Permanent, Fresher

Pay: ₹30,908.99 - ₹45,098.74 per month

Benefits:

Health insurance Paid sick time Provident Fund
Work Location: In person