Regulatory Affairs Senior Associate III
A rapidly expanding global biopharmaceutical company is advertising a vacancy for a Regulatory Affairs Senior Associate III position in their UK office. The organisation is dedicated to being leaders in innovative medicines and vaccines. This is an exciting opportunity to work with a dynamic and innovative company that is rapidly changing the face of the personal healthcare industry.
- Assist in the identification and resolution of data-entry- related errors within the specified region.
- Develop standard responses for common queries which can then be used as "mini refreshers" for the HRM Community of Practice meetings.
- Assist in enforcing and supporting regional procedures to ensure HRM data entry and usage compliance.
- Support, and at times lead, efforts surrounding HRM regional specific projects and maintain appropriate metrics.
- Assist in the implementation of HRM data quality strategies in the region and support users in the execution of the strategy at the country level.
- Stand up and support regional communities of practices with the region.
- Assist in, and where appropriate take the lead in, the evaluation of metrics from the HRM data monitoring plan to determine where process changes, communication, and training/retraining may be needed to improve overall data quality.
Skills and Requirements:
- Bachelor's degree. with 6 years of industry experience, at least 5 of those in a regulatory/compliance industry with emphasis on system support OR Master's Degree with a minimum of 4 years of industry experience in a regulatory/compliance industry with emphasis on system support.
- Knowledge of EU regulatory procedures, e.g. MRP/DCP, CP.
- Proven experience analysing information in support of data entry activities.
- Demonstrated project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Numhom Sudsok at +44 203 871 8093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.