Essential Function
The Regulatory Assistant will provide technical, process-related and administrative support to regulatory team.
Reports To
Director/ Executive Director
Key Accountabilities:
- Provide regulatory advice and strategic support for Phase I to IV clinical studies and experience in various therapeutic areas, including preparation of clinical trial applications, amendments and responses to support European and International markets for multi-centre studies
- Manage the activities relating to the preparation,annotation,and maintenance of SmPCs, PILs and core datasheets(CCDS) for pharmaceutical products.Facilitate meetings with key constituents to develop CCDSs. Conduct literature searches and documents summarizing literature to assist with the development and annotation of CCDSs.
- Generate and maintenance of regulatory documentation for global registration and change control activities for medicinal, cosmetic and medical device products
- Liaise with regulatory authorities in order to respond to regulatory comments.
- Responsible for preparing, submitting and co-ordinating eCTD licence dossier upgrades to national Marketing Authorisations, ensuring compliance with EU and global requirements .
- Keep upto date with current, worldwide regulatory knowledge, trends and developments
Skills
- Analytical and problem solving skills
- Able to perform basic searches via the internet or other comparable data repositories
- Good interpersonal skills
- Good verbal / written communication skills
- Good organizational and prioritization skills
- Ability to work collaboratively and effectively in a team environment
- Client focused approach to work
- Knowledge of medical terminology
- Experience with computer applications
Education
- Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification/work experience (PhD preferred)
Language Skills
Minimum Work Experience
- Related experience gained in a healthcare environment is an advantage
EmoticonEmoticon