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Job Details

Regulatory Officer Submissions

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9676
Closing Date: 23 Mar 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global pharmaceutical company, are currently recruiting for a Regulatory Officer Submissions. This is a 12 month contract role initially.

Requirements:

Our client, a global pharmaceutical company, are currently recruiting for a Regulatory Officer Submissions. This is a 12 month contract role initially.

Role

  • 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 global markets
  • Compile regulatory components of annual product quality review (PQR)and PSUR/PBER
  • Archive the registration documentation according to internal standards; introduce and regularly update internal RA databases
  •  Perform assigned tasks with the highest quality and in accordance with established internal timelines and guidelines

DUTIES
DOSSIER MANAGEMENT 
1.    Tasks related to the RA Plan 
2.    Compilation of registration dossiers for identified countries
3.    Submission and registration process
4.    Maintain the assigned products’ marketing authorisations in territory 
5.    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.

Requirements

  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • Experience in a regulatory affairs environment essential
  • 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. 

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

Apply for this job: Regulatory Officer Submissions

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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