Collins McNicholas

Role Responsibilities:

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

Qualifications and Experience Required:

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

Skills Required:

Skills:

  1.  Familiarity with cGMP in pharmaceutical manufacturing.
  2.  Familiarity with concepts of Regulatory Approval process for both new drug developments (human and veterinary), and human generic pharmaceutical products.
  3.  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.
  4.  Working knowledge of EDMS (Electronic Document Management System).
  5.  Competent in the use of Microsoft office.

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email eloisa.ruiz@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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