Senior Regulatory Affairs Officer

Responsibilities
Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements
Manage international regulatory submissions according to company strategy and ensure registration deadlines are met
Respond to Health Authorities' queries and deficiencies in a timely manner
Liaise with other departments to support the timely introduction of new products into markets
Work as part of a team dealing with global registrations and providing regulatory support to all operational departments within the company
Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner
Communicate Health Authority approvals/final decisions to the relevant departments
Build departmental awareness of local regulatory requirements in global markets
Assess the impact on existing files when new regulatory requirements are issued
Archive the registration documentation according to internal standards; introduce and regularly update the internal RA database
Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines
Dossier management
Assist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategies
Proactively inform the RA Manager and other involved functions regarding all identified risks related to the planned MAA
Submit Marketing Authorisation Applications (MAA) to Health Authorities according to the registration plan and company\'s registration strategy
Obtain scientific advice from Health Authorities by liaising with the Health Authorities and preparation of all the required documents
Attend regulatory strategy or submission meetings with Health Authorities
Contribute to reviewing regulatory aspects of in-licensing contracts and agreements
Compilation of registration dossiers for identified markets
Review of regulatory submissions/MAAs for accuracy, completeness and compliance with EU or relevant Health Authority regulations and relevant guidelines; ensure that all specific national requirements are met
Compile the hard copy and/or eCTD of the registration dossier (depending on specific in-country registration requirements)
Identify and then obtain any deficient information in order to complete the compilation within the allocated time frame
Raise all identified risks related to the quality of the dossier in order to meet submission deadlines, without compromising the quality of the submission
Auditing the licensor's registration dossier vs. EU guidelines and, if relevant, specific national requirements as part of the in-licensing process in order to evaluate and assess its acceptability and identify all future possible major Health Authority deficiencies
Submission and registration process
Prepare, as per internal process, the data needed to make all required registration fees in a timely manner
Dispatch the documentation in the appropriate manner in order to deliver it to the relevant Health Authority or local Regulatory Service Provider or local Marketing Authorisation Holder (MAH); ensure the delivery is confirmed
Answer all queries received from Health Authorities during the validation phase of registration
Ensure all internal RA database are updated with any new specific national requirements
Coordinate and communicate trade name rejection
Address all deficiencies identified by the Health Authority in an appropriate manner within the required timelines.
During the Response to Questions preparation liaise closely with internal/external contacts, relevant departmental staff and Health Authorities to ensure efficient and timely product registration
Communicate any change in status for assigned tasks.
Raise all identified risks related to the deficiencies from Health Authorities which might cause negative decision of procedure or delays in timelines
Monitor planned approval timelines and if necessary intervene in order to facilitate approval and minimise registration delays
Organise national translations in efficient and organised manner in order to meet strict registration timelines during national phase of registration (EU: MRP, DCP, CP, Work-sharing procedure)
Co-ordinate national phase with the Health Authority, Artwork Department, PV Department, local affiliate or local Regulatory Service Providers/local MAH to resolve any issues related to national translation of product information in order to obtain Marketing Authorisation
Review Marketing Authorisation/Registration Certificates for errors and ensure successful correction
Update and archive registration documentation according to the internal standards
Communicate MA approvals to all relevant personnel and update the relevant entries in all RA databases
Organise the handover of required data from dossier and registration process to allow efficient preparation for the first launch and marketing
Maintain the assigned products' marketing authorisations in Markets
Provide regulatory input to product lifecycle planning, including building of renewal plans, assessing the risk related to \"sunset clause\" provision
Provide regulatory assessment and strategy and regulatory impact assessment for change controls
Analyse the input of cumulative product changes to current product submissions
Impact assessment on existing files when new requirements are issued
Review, prepare and compile the registration documentation required to maintain MAs, for example variations (required internally or requested by Health Authorities), any supplements to dossiers, notification, renewals
Inform other relevant functions about all relevant submissions e.g. variations, renewal and their predicted approval time
Compile the regulatory component of annual product quality review (PQR) and PSUR/PBER
Projects and team working
Work as part of a team dealing with global registrations and provide regulatory support (guidance and strategy) to multi-disciplinary team and all operational departments within the company
Liaise with the Global IP and (if required) other Hubs with respect to Global dossiers and related projects in order to ensure required documentation is available on time, fully complete and accurate
Report monthly on status of assigned projects
Acting as a mentor and supervisor to less experienced staff
If necessary substitute and/or give support to the departmental colleagues in order to ensure all tasks assigned to the team are timely performed
Share and exchange knowledge gained from everyday work and trainings with departmental staff
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 RA Manager in order that they are implemented without delay within the relevant department
Investigate and maintain regulatory knowledge within the department
Provide regular training within the department regarding specific regulatory affairs topics assigned by the departmental manager and communicate this topic to the RA Department
Contribute in development of new regulatory policies, processes, rules of cooperation and SOPs and train key personnel on them
Education & Job Related Work Experience Required
Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
Min 4-5 year experience in a regulatory affairs environment
Min 4-5 year experience in the pharmaceutical industry
Detailed knowledge of EU and other regions current registration requirements for dossier preparation and procedure running
Solid knowledge of specific national requirements in EU and other regions
Knowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.)
Seniority level
Associate
Employment type
Full-time
Job function
Health Care Provider
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr