Regulatory Affairs Officer

  • Reference: CJ47174y
  • Job Type: Permanent
  • Location: Munster, Waterford
  • Category: Science, Pharmaceutical & Food

Role Responsibilities:

  • Licence maintenance support to customers, Regulatory agents and internal departments
  • Regulatory Compliance liaison with QA
  • Support licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East
  • Dossier preparation for submission to all target markets, including liaison with R&D, QC, and Production as well as external experts where required
  • Strategic planning of regulatory activities in target markets for products (human and veterinary; solid oral dosage forms, fill finish and inhalations)
  • Support activities in the areas of Bio-equivalence and Clinical safety and efficacy study management

 

Qualifications and Experience Required:

  • Minimum B.Sc. or a third level qualification required, preferably in Chemistry, Pharmacy or Pharmacology.
  • Previous pharmaceutical experience required; 1-2 years regulatory affairs experience desirable.

 

Skills and Competencies Required:

Skills:

  • Familiarity with cGMP in pharmaceutical manufacturing.
  • Familiarity with concepts of Regulatory Approval process for both new drug developments (human and veterinary), and human generic pharmaceutical products.
  • Technical knowledge of analytical/formulation development of pharmaceutical products including solid oral dosage forms (tablets, hard capsules, soft gel capsules), fill finish (biologics and small molecules) and inhalations.
  • Working knowledge of EDMS (Electronic Document Management System).
  • Competent in the use of Microsoft office.

 

Competencies:

  • Planning and organising – effectively develop and implement plans to accomplish project objectives.
  • Communication – write, speak and present information effectively across communication settings.
  • Adaptability – maintain effectiveness in varying environments and with different tasks, responsibilities and people.
  • Problem Solving/Analysis – secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
  • Teamwork and Collaboration – working effectively with team / work group or those outside the formal line of authority (e.g. peers, senior managers) to accomplish organisational goals; taking actions that respect the needs and contributions of others, contributing to and accepting the consensus; subordinating own objectives to the objectives of the organisation.
  • Customer Service Orientation – making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customers’ needs; giving high priority to customer satisfaction.
  • Initiative – making attempts to influence events to achieve goals; self-starting rather than accepting passively; taking action to achieve goals beyond what is required; being proactive.

 

For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email rory.walsh@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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