I am looking for a Dossier Manager to join a Global Pharmaceutical organisation based out of Surrey, UK.
The Dossier Manager is accountable for operational management for dossier build and/or publish of regional and/or national regulatory dossiers to designated Health Authorities (HA’s).
On behalf of Global Regulatory Sciences (GRS), Dossier Managers manage technical aspects, ensuring delivery of X-regional, regional and/or national regulatory dossiers -development, initial application and subsequent lifecycle updates (compliance and maintenance).
Key Requirements -
Adhere to FDA regulations 21 CFR 312 and 21 CFR 314, coordinate US regulatory compliance submissions which are driven by relevant Event and/or Calendar to ensure the organisations' legal obligation.
Monitor and verify Suspected Unexpected Serious Adverse Reaction (SUSAR) arising from clinical trial, report to Regulatory Authority within agreed timeline to protect patient’s safety.
Submit investigator package (FDA 1572 form and CV of the principal investigator) to Regulatory Authority within 30 days to guarantee patient’s safety and right when new investigator added in the clinical trial study.
Coordinate and notify Regulatory Authority of any Advertising and Promotional Labelling materials on or before its Date of First Use (DOFU) to protect public health by assuring the prescription drug information is truthful, balanced and accurately communicated in accordance with existing regulation and present guidance.
Communicates important information to healthcare providers & patients by the promotional materials.
Qualifications:
B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
Associate: Advanced English language required. Sr. Associate / Manager: Advanced to Fluent English language required. Multilingual skills desirable.
Technical Skills
Advanced Microsoft Office Suite skills.
Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards, including fluency with publishing and Document Management tools.
Experience with building & publishing a full paper and electronic submission.
Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
12 Month Hybrid Assignment based out of Walton Oaks, Surrey
PAYE - £19.75 p/h Umbrella - £22.13