Posted on 12 months ago by Gerry Kennedy
Regulatory Affairs Officer
The Regulatory Affairs Officer will ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU standards and corporate requirements;
Manage international regulatory submissions according to company strategy and ensure meeting registration deadlines, via timely answering Health Authorities' queries and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, to support the timely introduction of the new product into markets;
Maintain assigned products' Marketing Authorisations via timely variations and renewals submissions and their approvals;
Build departmental awareness of local regulatory requirements in global markets;
Compile regulatory component of annual product review and PV requirements
Archive the registration documentation acc. to internal standards; introduce and regular updates to the internal RA database;
Perform assigned tasks with the highest quality and in accordance with established internal timelines
Reporting to the Head Global Regulatory Affairs
Tasks related to the RA
Submit the Marketing Authorisation Applications (MAA) for assigned projects to Regulatory Authorities (MOH) in territory according to the annual registration plan and company's registration strategy.
Proactive inform supervisor and other involved functions regarding all identified risk related to the planned MAA submissions for assigned projects.
Support the process of scientific advice obtaining from MOH by liaison with Agency and preparation of all required data/documents.
Compilation of registration dossiers for identified countries
Review of all assigned regulatory submissions/MAAs for accuracy, completeness and compliance with EU regulations and relevant guidelines; ensure that all additional specific country national requirements are met.
Compile the hard copy of registration dossier and/or eCTD relevantly to specific requirements of the country of registration.
Identify and then obtain any deficient information to complete the compilation within the allocated time frame.
Raise all identified risks related to the quality of the dossier to meet submission deadlines, without compromise in quality of the submission.
Complete any Gap remediation identified, to ensure these are completed in accordance with the schedule;
Submission and registration process
Prepare, as per internal process, the data needed for timely payment of all required registration fees.
Dispatch the documentation in the appropriate manner, to deliver it to the relevant MOH; ensure the delivery is confirmed.
Answer in a timely manner all administrative queries risen by HA during the validation phase of registration - up-date the internal RA database with any new specific national queries; coordinate name rejection acc. to internal company process and, if required, submit relevant name variation application within appropriate timelines.
Address all deficiencies identified by the MOH in successfully and adequately manner within the required timelines. During the Response to Questions, preparation interacts closely with internal/external contacts, staff and agencies to ensure efficient and timeous product registration. Communicate of registration status for assigned projects as per internal process. Raise all identified risks related to the deficiencies from MOH which might cause procedure failure or delays. Monitor the planned approval time for assigned projects - if necessary intervene to facilitate approval and thus minimize registration delays. Order the national translations inefficient and organised manner to meet strict registration timelines during national phase of registration (EU: MRP, DCP, CP); cooperate closely with MOH, artwork coordinator, medical information staff, marketing as well as affiliates (or agents) in country of registration to solve any issues related to national translation of medical information to obtain Marketing Authorisation on predefined time. Screen Marketing Authorisation (registration certificates) for errors and ensure successful correction.
Update and archive registration documentation acc. to the internal standards.
Inform other relevant functions about MA granting - appropriately and timely up-date all RA database, hand over all required data from dossier and registration process to allow efficient preparation for the first launch and marketing.
Maintain the assigned products' marketing authorisations in the territory
Review, give an opinion (re. registration requirements) and track the change control internal process.
Review, prepare and compile the registration documentation required to maintain the assigned products' MAs, such as any variations (required by the company or Regulatory Authorities), any supplements to dossiers, notification as well as renewals.
Inform other relevant functions about variations, renewal, etc. submission and their predicted approval time.
Compile regulatory component of annual product review and PV requirements.
Update and maintain all appropriate tracking documents as required to ensure accuracy and currency.
Complete all administrative functions to support and accurately reflect the current status of the product details within the dossier.
Projects and team working
Actively participate in assigned projects by providing regulatory guidance and strategy to a multi-disciplinary team.
Work as part of a team dealing with global registrations to ensure required documentation is available on time, fully complete and accurate.
If necessary substitute and/or give support to the departmental colleagues in order to ensure all tasks assigned to the team are performed in a timely manner
Share and exchange the knowledge with departmental staff gained from everyday work and training.
Report bi-weekly on the status of assigned projects.
Regulatory Good Practice
Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
Ensure that any regulatory changes communicated to the pharmaceutical industry by Regulatory Authorities are raised to the supervisor in order to implement them without delay within the department.
Maintain the current knowledge within the department about assigned by departmental Head specific regulatory affairs topic - perform regular training re. this topic for the rest of RA group.
Minimum Skills/ Experience
Life sciences (BSc in Chemistry/ Biology/ etc.) or pharmacy degree
1 - 2-year experience in a regulatory affairs environment
1 - 2-year experience in the pharmaceutical industry.
Detailed hands-on knowledge of EU current registration requirements for dossier preparation and procedure running
General knowledge of the pharmaceutical industry
Knowledge of IT tools utilised in RA department
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