Description
Looking to work for a global pharmaceutical with a niche skill set? This role could be something you'd be interested in. if so please read further below:This company is looking for a Senior Regulatory Information Officer Will support and enable the implementation of the regulatory information Management technology strategy to support the Global Regulatory Affairs (GRA) business and its partner functions. You will be responsible for project management of various regional and global (new and ongoing) projects within Global Regulatory Operations specifically within the Regulatory Information Management group.
Skills & Experience
You will hold a Bachelor's Degree in Life Sciences or Information Technology (or equivalent). As an ideal candidate you should have extensive experience in Pharmaceutical Regulatory Affairs, particularly in regulatory submissions process (publishing). Knowledge in global regulatory requirements, industry regulatory standards will be required for this role. A solid understanding of the drug development process, generics and branded product development would be a plus.
Main Responsibilities
- Act as the main contact between the business units, information technology and support teams
- Provide business project management to support the delivery of IT systems / upgrades and new implementation projects with focus on regulatory data management and submission publishing. Includes the provision of business consulting support for regulatory functions as appropriate for shared and global solutions.
- Work across regions and functions with staff at all levels to ensure regulatory systems are developed and enhanced to meet the diverse regulatory business needs
- Leverage deep business or technology expertise to partner with the above functions; understand evolving regulatory guidance; understand new user requirements and translate those into project proposals for change
- Analyse and challenge stated requirements in a professional manner when required to derive actual, clear, or hidden requirements
- Provide business support for production systems in scope
- health authority regulations and programs. Maintain current knowledge of existing and emerging
- International and domestic travel will be required, variable based on business need 10-20%
If this is something you may be able to do or are considering please do email me on L.khan at realstaffing.com alternatively to recommend a friend for the role email me or call me on .
Thank you.
Latifah Khan