UK - Electronic Submission Specialist
ProClinical is advertising a vacancy for a Senior Specialist, Regulatory Affairs position with a major biotechnology company that prides itself on its extensive pipeline and commercial portfolio in oncology and immunology. The position is with the company's office in Liverpool. This is an exciting opportunity to join an innovative company that delivers life-changing drugs with over 4000 employees in over 50 countries worldwide.
- Supporting Global Regulatory Operations
- Leading in the coordination, preparation, and submission of all INDS/NDAs/MAAs & 510Ks and life cycle management in eCTD, as well as paper and NeeS formats.
- Creating, assembling, publishing, and verifying both major and routine regulatory dossier submissions, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, and Responses, etc.
- Maintaining all Regulatory and Health Authority submission archiving within specified time frames.
- Verifying all regulated electronic documents via workflows within the company electronic document management system.
- Adhering to required submission timelines, health authority publishing specifications, and internal working practices.
- Liaising with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide.
- Working with regulatory document authors to achieve resolution and ensuring that documents comply with regulatory and company guidance/template specifications.
- Closely interacting with authoring community to track availability of deliverables.
- Maintaining working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
Skills and Requirements:
- BA/BS Degree or equivalent experience.
- Two pharmaceutical industry experience, specifically in Regulatory Operations.
- Demonstrable experience with compiling eCTD submissions in a publishing tool (e.g., eCTDXPress, eCTDManager, ViewPoint, etc.).
- Technical knowledge of electronic publishing systems/document management systems and software.
- Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic.
- Proficiency with MS-Office Suite and Adobe Acrobat applications.
- Knowledge of health authority procedures/guidances regarding electronic submissions.
- Ability to balance multiple tasks to meet priorities and timelines.
- 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 Kelechi Dyke at +44 203 854 0200 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.
Highly Competitive Salary
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