Careers in Clinical Research
United States Department of Education in an evidence based meta-analysis of various studies conducted over a period of 12 years concluded that students who acquired higher education through online mode performed much better than those in regular class room courses. (www.ed.gov/about/offices/list/
opepd/ppss/reports.html)
Careers in Regulatory Affairs
With the fast growth of clinical research industry there is a tremendous need of experienced regulatory professionals to work in the regulatory affairs departments of drug development companies from development to market and beyond. The role of a regulatory professional is to provide strategic regulatory advices and possess the ability to liaise at all levels to form new client relationships and develop existing ones. This is a new and exciting field, in which you will be able to expand your existing skills in a variety of different areas. Following are some main responsibilities of regulatory affairs professionals:
- Provide regulatory support for assigned clinical research projects by interacting with various departments/ teams to ensure filing of required regulatory documents on schedule as per regulatory norms
- Design regulatory deliverables and submit documents to regulatory authorities
- Keep up to date knowledge of global regulatory development and provide support to existing and emerging market
- Assist and guide subordinates in the team to interact with customers and partners
- Interact with regulatory authorities by acting as a single point of contact in order to respond to regulatory authority comments
- Ensuring proper training is provided to the team members and Good Regulatory Practices are followed within the team
- Preparation of registration dossiers for regulatory submission in regulated markets
Education:
- Master's or Bachelor's degree preferably in Life Sciences
- Excellent knowledge of ICH GCP and regulatory guidelines
- Proven experience in the preparation of regulatory submissions
- Good understanding of worldwide regulatory legislation, guidelines and customer practice
Skills:
- Customer focus
- Well developed organizational and management skills
- Ability to work as part of a team and as an individual
- Demonstrate management skills and ability to meet timelines
- Dedicated with strong sense of responsibility
- Should be abreast with industry trends and compliance
- Excellent verbal and written communication skills
