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Job Details

Regulatory Affairs Officer - Pharma and Medical Devices!

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD8480
Closing Date: 02 Jan 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a growing Dublin based pharmaceutical company are currently recruiting for a Regulatory Affairs Officer for pharmaceutical and medical device products.

Requirements:

Our client, a growing Dublin based pharmaceutical company are currently recruiting for a Regulatory Affairs Officer for pharmaceutical and medical device products. 

Main Objective of Role

  • Ensure timely preparation and compilation of registration dossier for assigned projects in accordance to 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, in order to support the timely introduction of new product into markets;
  • Maintain assigned products' Marketing Authorizations 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 PSUR
  • Archive the registration  documentation  ace. To internal standards; introduce and regular up-dates to the internal RA database
  • Perform assigned tasks with the highest quality and in accordance to established internal timelines.


Duties
DOSSIER MANAGEMENT
1.     Tasks related to the RA Plan
•    Submit the Marketing Authorizations Applications (MAA) for assigned projects to Regulatory Authorities (MOH) in territory according to the annual registration plan and company's registration strategy.
2.     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 country of registration.
•    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  compromise in quality of submission.
•    Auditing the licensor's' registration dossier vs. EU guidelines and, if relevant, specific national requirements within the in-licensing processes in order to evaluate and assess on its acceptability and identify all future possible major MOH's deficiencies;

3.     Submission and registration process
•    Prepare, as per internal process, the data needed to timely payment of all required registration fees.
•    Dispatch the documentation  in the appropriate  manner in order to deliver it to the relevant MOH;
ensure the delivery is confirmed.
•    Answer in 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 ace. 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 interact 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. Rise all identified risks related to the deficiencies from MOH which might cause procedure failure or delays. 
4.     Maintain the assigned products' marketing authorisations in territory
•    Review, give 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 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 PSUR.
5.     Supply the complete and comprehensive handover file to the Registered Product department
•        Prepare the "master documentation" (containing all crucial correspondence and dossier up-dates required during registration procedure) to support all future post registration amendments and variations.
6.     Projects and team working
•    Actively participate in assigned projects by providing regulatory guidance and strategy to multi­
disciplinary team.
7.     Regulatory Good Practice
•    Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.

Requirements
•    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 knowledge of EU current registration requirements for dossier preparation and procedure running
•    Deep knowledge of specific national requirements in usual target registration countries
•    General knowledge of the pharmaceutical industry
•    Knowledge of Company's internal rules, SOPs and structure
•    Knowledge of IT tools utilized in RA department

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

Apply for this job: Regulatory Affairs Officer - Pharma and Medical Devices!

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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