Cache of job #13863909

Employer

Hartley People Recruitment

Job Title

Ra Office & Snr Ra Officer

Description

Regulatory Affairs Officer. The Role Understanding and familiarity with cGMP in pharmaceutical manufacturing. Familiar with concepts of Regulatory Approval process for both new drug developments. Technical knowledge of analytical/formulation development of pharmaceutical products including solid oral dosage forms. Develop and implement plans to accomplish project objectives. Maintain effectiveness in varying environments and with different tasks, responsibilities and people. 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. Work effectively with team / work group or those outside the formal line of authority (e.g. peers, senior managers) to accomplish organizational goals. Understand the customer (both internal and external); anticipating and providing solutions to customer’s needs; giving high priority to customer satisfaction. Influence events to achieve goals; self-starting rather than accepting passively; taking action to achieve goals beyond what is required; being proactive. The Person B.Sc. or a 3rd level qualification required, preferably in Chemistry, Pharmacy or Pharmacology. Previous pharmaceutical experience required. 1-2 years regulatory affairs experience desirable. Strong working knowledge of Electronic Document Management System. Competent in the use of Microsoft office. Strong communication skills. Snr Regulatory Affairs Officer The Role Licence maintenance support to customers, Regulatory agents and internal departments. Liaise with the Quality Department. 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. CMC Regulatory support to R&D and Clinical Managers for various dosage forms including solid oral dose fill finish and inhalations. Develop and implement plans to accomplish project objectives. Secure relevant information and identify key issues and relationships from a base of information. Make efforts to listen and understand the customer (both internal and external. Anticipate and provide solutions to customer’s needs; giving high priority to customer satisfaction. Support team members on designated projects. The Person Minimum B.Sc. (Bachelor of Science) degree, ideally in discipline of Chemistry, Pharmacy or Pharmacology (but any Science related discipline considered. Minimum 3 years’ experience in a regulatory affairs role in a pharmaceutical environment. 5 – 8 years regulatory experience preferable. Additional experience in pharmaceutical environment – e.g. Quality Control, R&D or Quality Assurance Department advantageous but not essential. Strong experience in Global Regulatory Affairs. Technical knowledge of analytical/development of pharmaceutical products. Working knowledge of Electronic Document Management System. Competent in the use of Microsoft office. Strong supervisory experience. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please callSaraon 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Production Supervisor, Production Manager, Lean Manufacturing, Six Sigma, GMP, FDA, Production, Engineering, Manufacturing, Pharmaceutical, Medical, Devices. ISO 9000, Manufacturing Manager, Operations Manager, Assistant Operations Manager, Production Team Leader, Line Manager, Line Leader. This job originally appeared on RecruitIreland.com.

Location

Waterford

Date Added

102 days ago

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