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Regulatory Officer Submissions Department Pharma

Job description

We are looking for an RA Officer to join submissions department within an international pharmaceutical client in Dublin West

Contact

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.

Job duties:

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.

Person profile:

  •          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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