Description
The key elements of the role will include:- Preparation and review of clinical trials applications to Regulatory Agencies and Ethics Committees globally
- Preparation and review of EMEA Scientific Advice briefing documents
- Preparation and review of pre-IND and End of Phase II briefing documents
- Maintain approvals including preparation and submission of amendments, Annual Reports, Pharmacovigilance updates etc
- Preparation and review of Paediatric Investigation Plans
- Summarise, tabulate, and format technical information (CMC, preclinical, and clinical) per regulations/guidelines to support regulatory applications
- Maintaining a working knowledge of, and ensuring compliance with, applicable ICH Guidelines, Regulatory Agency requirements and internal SOPs aiming to ensure completeness, scientific accuracy, regulatory compliance, and consistency with other key documents
- Management of Regulatory Affairs Consultants to obtain appropriate local expertise and input
A suitable candidate will need to be an experienced Regulatory Affairs professional with significant experience in the pharmaceutical industry. A background in Research and Development with significant CMC experience is essential. You will preferably already have experience in dealing with Regulatory agencies in the EU andUSAfor conduct of Phase II and III clinical trials.
You will have the following attributes:
- A thorough knowledge of the contents of briefing packages and clinical trial applications.
- Expertise to independently present complex information to senior management, consultants, and regulatory authorities.
- Significant CMC experience.
- Ability to produce high quality, well written, concise and neatly formatted documents.
- Demonstrable ability to focus and work with attention to detail.
- Ability to pro-actively understand complex information and plan accordingly
If this role is of interest to you and you woud like to discuss it further then please contact Peter Duvall at Real Pharma on
To find out more about Real please visit www.realstaffing.com