Regulatory Affairs Officer Submissions

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Job Description

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Regulatory Officer Submissions This is a permanent, full-time role.

Objectives

  • Ensure timely preparation and compilation of registration dossier components in accordance to EU or relevant Health Authority standards, and corporate requirements
  • Under supervision of the senior RA person (if required), manage international regulatory submissions according to company strategy and ensure registration deadlines are met
  • Responding to Health Authorities' queries and deficiencies in a timely manner
  • Liaise with other departments to support the timely introduction of new product into markets
  • Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner
  • Communication of Health Authority approvals/final decisions to the relevant departments
  • Build departmental awareness of local regulatory requirements in relevant markets
  • Compile regulatory components of annual product quality review (PQR) and PSUR/PBER

DUTIES

DOSSIER MANAGEMENT

  1. Tasks related to the RA Plan
  • Under 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.
    1. 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.
    2. 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.
    3. 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.
    4. 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.

Requirements

  • 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.

For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail LDunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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Linda Dunne

Senior Recruitment Consultant ldunne@thornshaw.com
  • Salary:Negotiable
  • Location:West Dublin
  • Type:Permanent
  • Category:Science,Thornshaw
  • Ref.no:JO-2004-449502_14