Senior RA Officer
|Job Title:||Senior RA Officer|
|Contact Name:||Alex Young|
|Job Published:||March 16, 2017 19:17|
- POSITION SUMMARY
- OVERALL JOB RESPONSIBILITIES
List and describe the position's key responsibilities in order of importance, and indicate the results expected, approximate percentage of time spent on the responsibility. (Percentages should add up to 100%) For each, describe in simple terms what the job holder must do to accomplish the main purpose of the job Insert additional rows as needed.
Results Expected/ Target
% of time spent
Successfully interact with the project and functional teams in India to ensure that data generated is appropriate and will be compiled and submitted in accordance with EU requirements.
Ensure all filings are happening on time
Provide support and guidance to the Global Regulatory Affairs EU team when evaluating new projects as part of the European Portfolio Meeting (EPM) process and Product Portfolio Meeting (PPM) process, by providing national regulatory insight and opinion on risks.
Ensure highlight of national requirements for new product applications
Direct communication with regulatory authorities to facilitate productive dialogue on all new and existing product submissions and other relevant issues.
.Ensure promptly and accurate communication with relevant national regulatory authorities
Timely generation and submission of regulatory applications (generally DCP, MRP,CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase for MA issue following closure of the European Regulatory Procedures.
Complete dossier submissions for projects in a timely manner.
Oversight of Regulatory Tracking Database. Liaise with contract services provider to ensure that the Regulatory Tracking Database is able to provide relevant and timely information on pending and approved products.
Ensure documentation are provided in timely manner
Post-approval activities including maintenance of approved Mas (variation, Renewal & PSURs) and launch activities.
Ensure all request from authorities are answered appropriately
Assistance in compilation of compliance files for new licence approvals and updating compliance files during life cycle of the product where necessary.
Ensure all necessary information applicable for WE markets is provided to EU GRA
Liaise with external companies with respect to in-licensing and out-licensing activities and any associated regulatory issues as required.
Generation of accordingly regulatory strategy
Perform dossier due diligence activities to advise on regulatory strategy to the business
Provide regulatory strategy, timelines and cost for an in-license project
- KEY INTERFACES / INTERACTIONS
Internal Interfaces ( Other than Direct Reports)
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