Junior Regulatory Associate
This vacancy has now expired. Please see similar roles below...
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.
Job Responsibilities:
- 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.
To Apply:
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.
#LI-116788626_PD1
Related jobs
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated QC Microbiologist to support our vaccine manufacturing site. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
München (81249), Deutschland
Proclinical sucht einen engagierten regionalen Vertriebsleiter für die Osthälfte Deutschlands im Bereich Urologie.
Highly Competitive
Deutschland
Proclinical are currently in search of a dynamic Statistical Project Leader.
Highly Competitive
Tuttlingen, Germany
Proclinical sucht einen Systems Engineer - Instruments für einen Kunden aus der Medizintechnik-Branche.
Highly Competitive
Singapore River, Singapore
Proclinical are recruiting for a Senior eCommerce Manager APAC (6 months maternity cover) to join a pharmaceutical organisation.
Highly Competitive
Tuttlingen (78532), Deutschland
Proclinical auf der Suche nach einem Systems Engineer (m/w/d).
Highly Competitive
Singapore
Proclinical is seeking a dedicated Automation Engineer to provide technical support for smooth manufacturing operations.
Highly Competitive Salary
Lexington, USA
Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.
Highly Competitive Salary
Indianapolis, USA
Proclinical is seeking a dedicated and innovative Electrical Engineer to join our Engineering Operations Team. This is a permanent position located in Indianapolis, IN.
Highly Competitive Salary
New Haven, USA
Proclinical is actively seeking an Upstream Associate Scientist. This is a contract position located in New Haven, CT.