Regulatory Affairs Executive

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