Regulatory Affairs department is responsible for all communication with regulatory agencies such as FDA, EMA, MHRA etc.
The global regulatory affairs teams and regulatory specialists in the bio-pharmaceutical and medical devices sector occupy a main and vital role compared to all the other functional departments. Regulatory affairs professionals are in high demand and the career opportunities in this area are phenomenal.
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Ever since the field of pharmaceutical drug development, manufacturing and marketing became regulated by regulatory agencies such as the US FDA, EMEA, MHRA etc, the area of Regulatory Affairs has opened up new opportunities of employment. The growth of the clinical research industry has pushed this demand for skilled regulatory affairs professionals even further. Regulatory Affairs careers in clinical research are very satisfying and exciting as the regulatory function is vital in making safe and effective healthcare products available worldwide. Roles and responsibilities of regulatory professionals often begin in the research and development phases for each product and continue throughout the product life cycle. Regulatory Affairs professionals keep themselves updated with global and local regulatory policies, procedures and trends. They also maintain understanding of scientific and technical background of healthcare products. Regulatory affairs department adds great value to drug development worldwide by comprehending and interpreting the regulatory environment and suggesting pathways for reducing the time to market.
Some major responsibilities of professionals working in regulatory affairs departments are:
- Formulating a drug development strategies
- Providing regulatory consultation
- Conducting gap analysis
- Developing product dossiers and their submission to applicable regulatory agencies
- Communicating with regulatory agencies
- Providing regulatory affairs related training to applicable team members and/or departments
Competencies & Skills:
Multiple competencies and skills are required to make become a regulatory affairs professional. Some of them are:
- Thorough understanding of the drug development process with sound knowledge of ICH-GCP
- Comprehensive writing skills with good command over written and spoken English
- High Confidence
- Multi-tasking ability
- Self-motivation and ability to work independently
- Strong customer focus
- Knowledge of basic word and data processing software's like MS Word and Excel
- Master's or bachelor's degree in any Life Science field is preferred
- Strong experience in (or knowledge about) the preparation of regulatory dossiers
"The regulatory affairs course that I have done was very detailed. I was able to get a fair understanding of the different regulatory bodies and regulations related to clinical research."
Clinical Trial Investigator