Regulatory Executive Senior - Level 2
A top 10 global pharmaceutical company is currently recruiting a Regulatory Executive Senior - Level II. This organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in the UK, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the clinical field.
- Ensuring the delivery of Regulatory Records & Data Management (RRDM) initiatives and projects and overseeing operational teams ensuring the timely execution of RRDM based requests.
- Efficiently completing all Regulatory Records & Data Management (RRDM) activities assigned in compliance with internal and external procedures/regulations.
- Leading and motivating teams of Regulatory Records & Data Management associates, ensuring appropriate knowledge and competency is built and maintained to support existing and emerging workload.
- Leading initiatives and projects to support evolving internal and external regulatory requirements impacting our Regulatory Information Management processes, such as Registration Tracking, EVMPD, IDMP, and CMC Technical Details.
- Partnering with GRPD Regulatory Systems, company IT, and external vendors to optimise delivery and using regulatory data management systems and associated processes.
- Collaborating with Regulatory Operations functions in the company to maximise the alignment and efficiency of Registration Data Management across these Business Units.
- Defining system procedures, including reports, to support Business Processes effectively and managing change control procedures to ensure full impact assessment and robust implementation of change.
- Identifying cases of potential non-compliance with internal and external procedures and following appropriate procedures to investigate and, where necessary, identify risks, appropriate corrective actions, and prevent future issues.
- Developing metrics for, evaluating, and improving performance of the RRDM team.
Skills and Requirements:
- Demonstrable skill and experience in a similar or relevant field/capacity.
- 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.