Celgene Submissions Specialist – Global Regulatory Operations in Hillingdon, United Kingdom
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
You will support Regulatory Affairs colleagues in the coordination, preparation, and submission of all INDS / NDAs / MAAs and life cycle management of these submissions using EDMS and electronic publishing systems.
Role and Responsibilities
Responsible for planning, compiling, tracking, dispatching, and archiving regulatory documents and submissions in both paper, eCTD, and other electronic format.
Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, DSURs, PIPs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, Briefing Books, etc.
Technical verification of regulated documents via workflows within electronic document management systems.
Liaise with functional source areas (clinical, nonclinical, quality, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
Responsible for maintenance of all Regulatory and FDA correspondences (archiving into electronic document management system) within specified time frames.
Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
Other responsibilities related to the above within Celgene as a whole, as assigned.
Bachelor’s Degree (or equivalent experience) with at least Regulatory Operations and Pharmaceutical industry experience required.
Skills and Knowledge Requirements
Knowledge of IND, NDA, MAA, CTD requirements and guidelines; both paper and electronic required.
Must have experience working in Electronic Document Management Systems (EDMS).
Experience publishing eCTD using electronic publishing system and tools.
Knowledge of industry trends regarding electronic submissions.
Proficiency with MS-Office Suite and Adobe Acrobat application.
Ability to balance multiple tasks to meet priorities and timelines.
Self-starter with superior time management skills, and ability to work independently and in teams.
Attention to detail.
Submissions Specialist – Global Regulatory Operations
Location: Hillingdon, England, UK
Job ID: 17001059