The M.Sc Clinical Research is the most happening field in today’s world. The changed lifestyle of the people has given rise to new diseases among humans. The pharmaceutical companies are forced to develop new drugs and treatments to treat these diseases.
The pharmaceutical companies conduct extensive field trials for the drugs that are developed by them. The M.Sc Clinical Research students are skilled professionals and are required in large numbers by many of these pharmaceutical companies.
These pharmaceutical companies offer different job roles for the skilled M.Sc Clinical Research students, but the present article discusses some of the crucial and important job roles available for the M.Sc Clinical Research students. The article discusses the important roles available for skilled professionals that offer good salary packages and better career opportunities.
Let’s discuss them in detail below:
Regulatory Affairs officer
As a regulatory Affairs officer one should ensure to have the preoperative licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy.
Role of a Regulatory Affairs Officer
As a regulatory Affairs Officer one will act as a crucial link between the company and regulatory authorities. As a Regulatory Affairs officer one is required to combine his/her scientific knowledge of scientific, legal and business issues and ensure that the products developed, manufactured or distributed by a range of companies meet the required legislations.
Responsibilities of a Regulatory Affairs Officer
As a Regulatory Affairs Officer one is needed to:
- Ensure that a company’s products comply with the regulations of the regions where they want to distribute them
- Keep up to date with national and international legislation guidelines and customer practices
- Collect, collate and evaluate scientific data from a range of sources
- Develop and write clear arguments and explanations for new product licences and licence renewals
- Prepare submissions of licence variations and renewals to strict deadline
- Monitor and set timelines for licence variations and renewal approvals
- Work with specialised computer software and resources
- Write clear, accessible product labels and patient information leaflets
- Plan and develop product trails and interpret the trial data