Junior Regulatory Associate
ProClinical is advertising a vacancy for a Junior Regulatory Associate with one of the largest global pharmaceutical companies in the world. This organisation's dedication to developing high-quality medicine to meet real world problems makes this a very attractive position for a driven and hard-working incumbent who wishes to develop their career within a prestigious company. This position will be with their team in Liverpool.
- Supporting existing Regulatory Associates in obtaining information required to support Global Registration requests made through the Elanco Regulatory Tracking System and expedite legal treatment of documentation, when required.
- Assisting the CMC molecule managers by coordinating data collection for the MCSR process.
- Developing expertise in specific Quality Dossier requirements ( eg. VneeS, NtA, and CTD structure ) and then compiling UK dossier content accordingly.
- Aiding CMC Molecule Managers in general dossier construction, i.e. stability tables, batch release data, and tabular summaries.
- Supporting any future dossier collation and developing expertise in EDAS data entry.
- Supporting amendments made due to submission and approval.
- Communicating our Agency commitments and learn about Product registration details.
- Reviewing regulatory information as required for internal specification documents, PQRs, and stability studies.
Skills and Requirements:
- Fluency in English, in both a written and verbal capacity.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solving problems.
- 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 in 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 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Warren, New Jersey
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