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Regulatory Affairs Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Healthcare
  • Date posted: 27/08/2018
  • Job reference: BBBH15512


Regulatory Affairs Officer


Job Description:
To support the Regulatory Affairs Manager and Senior Regulatory Affairs Officers with activities associated with the registration of our clients products in Worldwide 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.

Responsibilities:

  • Licence maintenance support to customers, our clients 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 of our clients 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 our 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


Minimum 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.

Other Information:

Reports to Senior Regulatory Affairs Officer.

Skills & Behavioral Competencies:

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.


Competencies

  1. Planning and organising - effectively develop and implement plans to accomplish project objectives.
  2. Communication - write, speak and present information effectively across communication settings.
  3. Adaptability - maintain effectiveness in varying environments and with different tasks, responsibilities and people.
  4. 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.
  5. 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.
  6. 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.
  7. 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.