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

Advantages:

- Health insurance
- Paid sick time
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Executive (India)
🏢 Refined Reports Data
📍 India