Regulatory Affairs Registration Manager
A top 10 global pharmaceutical company is currently recruiting a Contract Regulatory Region Expert. 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 Belgium, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the clinical field.
- Coordinating and interacting with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents that feature in the regulatory dossiers/data-packages in order to meet the submission timelines.
- Ensuring that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fulfilled.
- Preparing cover letters, application forms, letters of intent, letters to request deadline extensions etc; Strong involvement in CTD Module 1.
- Exhibiting a very good understanding of and ensuring alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects.
- Coordinating, prioritising, and planning all the registration activities for the projects within area of responsibility to ensure that deadlines are met.
- Maintaining close communication with the Local Operating Companies (LOCs) to ensure shared objectives are achieved.
- Ensuring the tracking of relevant correspondence with Authorities and Local Operating Companies in archiving database (TRAC-IT).
Skills and Requirements:
- Knowledge of Regulatory legislation in at least one geographic area.
- Basic understanding of biologicals/vaccines.
- 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 Peter Duvall at +44 203 078 9542 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.
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