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Job Details

Senior Regulatory Affairs Officer Submissions

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD4939
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global pharmaceutical company, are currently recruiting for a Senior Regulatory Affairs Officer Submissions

Requirements:

Our client, a global pharmaceutical company, are currently recruiting for a Senior Regulatory Affairs Officer Submissions 

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 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

 

DOSSIER MANAGEMENT 
1.    Tasks related to the RA Plan 
2.    Compilation of registration dossiers for identified countries
3.    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); ensure that the delivery is confirmed.
•    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.
•    Co-ordinate and communicate trade name rejection 
•    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. 
•    Organise national translations in efficient and organised manner to meet strict registration timelines during national phase of registration (EU: MRP, DCP, CP, Work-sharing Procedure).
•    Co-ordinate national phase  with Health Authority, Artwork Department, PV Department, local affiliate or local Regulatory Service Providers/Local MAH to resolve any issues related to national translation of product information 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.

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. 

Requirements:
•    Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
•    Min 3 years of experience in a regulatory affairs role in industry. 
•    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.
•    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 task
•    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.

For more information 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: Senior Regulatory Affairs 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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