We are looking for an RA Officer to join submissions department within an international pharmaceutical client in Dublin West
If you are interested in this job apply below. I also have more senior roles within QC, QA, QP, RA, PV, Validation, CQV, and other areas of pharmaceutical, medical device and biologics companies. Send me an email to schedule a confidential chat (014744692) - to "andrius at sigmar.ie" about roles or salary levels within the sector.
Tasks related to the RA Plan
- Under the supervision of the senior RA person (if required), submit Marketing Authorisation Applications (MAAs) to Health Authorities according to the registration plan and company's registration strategy.
- Proactively inform RA Manager and other involved functions regarding all identified risks related to the planned MAA.
- Support the process of Scientific Advice from Health Authorities by liaising with the relevant Authority and preparing the necessary documents.
Compilation of registration dossiers for identified countries
- Review of registration dossier components for accuracy, completeness and compliance with EU or relevant Health Authority regulations and relevant guidelines; ensure that all specific national requirements are met.
- Identify deficiencies and risks associated with dossier quality and consult it with senior RA person and/or RA Manager.
- Raise all identified risks related to the quality of the dossier in order to meet submission deadlines, without a compromise in the quality of the submission.
- Compile the hard copy and/or eCTD of MA application, (depending on specific in-country registration requirements).
Submission and registration process
- Prepare, as per internal SOP, 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.
- Answer all queries received from Health Authorities during the validation phase of registration.
- Ensure all internal RA databases are updated with any new specific national requirements.
- 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 timeous product registration.
- Consult with senior RA person during RtQ document preparation.
- 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, inform RA Manager in order to facilitate approval and minimise registration delays.
- Co-ordinate national phase with Health Authority, Artwork Department, PV Department, local affiliate or local Regulatory Service Providers/Local MAH 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 territory
- Under senior RA person supervision (if required), review MAs in accordance with registration requirements and track change controls according to internal processes.
- Review, prepare and compile the registration documentation required to maintain MAs, for example variations (required internally or requested by Regulatory Authorities), any supplements to dossiers, notification, renewals.
- Inform other relevant functions about all relevant submissions e.g. variations, renewal, and their predicted approval time.
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 to implement them without delay within the relevant department.
- Investigate and maintain the regulatory knowledge within the department, review specific regulatory affairs topics, as assigned by RA Manager and communicate this topic to the RA department.
- Results and performance driven – deliver results that meet or exceed expectations
- Sense of urgency – responding to issues and opportunities in a timely manner
- Intellectual curiosity – willing to suggest and try new ideas
- Positive and pro-active approach to business tasks
- Excellent interpersonal and communications skills.
- A solutions provider with strong multi-tasking abilities
- Manage evolving deadlines effectively with regular feedback and updates.
- Enthusiasm and Drive to take ownership and drive process initiatives.
- Service orientation;
- Customer focused;
- Logical thinking;
- Information seeking;
- Positive ‘can – do’ attitude
- Be able to work autonomously and have good problem solving skills.
- Able to cope with evolving deadlines effectively with regular feedback and updates.
- Honest and trustworthy
- Respectful and highly personable
- Possess cultural awareness and sensitivity
- Flexibility & Confidentiality are key requirements for this role.
Work experience for the job
- Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
- Experience in a regulatory affairs environment required
- Experience in the pharmaceutical industry an advantage
- Working knowledge of current registration requirements for dossier preparation and procedure running an advantage
- Solid knowledge of specific national requirements in usual target registration countries an advantage
- IT tools utilised in RA department e.g. for Regulatory intelligence, eCTD, change control etc.
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