Regulatory Affairs Officer

Search Consultancy


Job ID :

13366


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Bsc,Master of Science,phD


Address 1 :

Western Europe,--Waterford,Waterford,


Key Skills :

Regulatory Affairs Officer


Salary :

Negotiable


Date Posted :

30 Oct, 2018



Company Name :

Search Consultancy


Location1 :

Waterford




Job Category :

Scientific Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Search Scientific has a fantastic opportunity in the South of Ireland for a Regulatory Affairs Officer to support the Regulatory affairs team with registration of our clients products in World Wide markets including US, EU and Japan, as well as Regulatory compliance liaison with QA for registered products. The role includes regulatory activities associated with new drug developments in both human and veterinary as well as generics.
Support activities for running Bioequivalence and Clinical safety and efficacy studies.


Duties and Responsibilities
* Licence maintenance support to customers,
* 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 the clients 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

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 organizing
* Communication
* Adaptability
* Problem Solving/Analysis
* Teamwork and Collaboration
* Customer Service
* Initiative

Qualifications & Experience

* 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.


Benefits

* Pension
* Health insurance
* Flexi-time policy
* Active Social Club

Please apply here or alternatively call Robyn Clendinning on 0141 272 7793

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.


Company Name:

Search Consultancy


Headquarters:

Campbell House,215 West Campbell Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

G24TT


Website:

www.search.co.uk


Employees:

100 - 499


Industry:

Pharmaceutical


City:

Glasgow


Phone No. :

01618358600


For more information,visit www.search.co.uk.

View all Search Consultancy Jobs



© 2018 Jobsinpharma - 4ward Technologies Ltd All rights reserved.