- Reference: CJ47174
- Job Type: Permanent
- Location: Munster, Waterford
- Category: Science, Pharmaceutical & Food
- 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:
- 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.
- 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 firstname.lastname@example.org
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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