Senior Regulatory Affairs Consultant
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Location: |
Leinster
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Qualifications: |
Degree |
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Experience: |
5-6 Years |
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Job Type: |
Permanent
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Salary: |
Negotiable |
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Consultant: |
Brian Christensen 01 6854747 |
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Senior Regulatory Affairs Consultant
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Senior Regulatory Affairs Consultant
Reporting to the MD and Director of Technical Affairs, this is a technical specialist position which requires someone expert in their field.
To provide guidance/technical support in the preparation of EU dossiers and National registration applications (training, proofing, summarising study reports and carrying out risk assessments etc).
Responsibilities:
• Provision of guidance/technical support in the preparation of EU dossiers and National registration applications for chemical products and substances(training, proofing, summarising study reports and carrying out risk assessments)
• Liasing with regulatory authorities on behalf of client companies as required
• Representing the company at client and/or regulatory authority meetings as required
• Keep updated on new developments and published guidance documents in own area of expertise
• Initiatives taken in business development and contribution to the profitability of the company
• Mentor for junior team members in dossier preparation and generals aspects of regulatory affairs
• Responsibility for assisting with business development
• To select CRO’s/external consultants (commissioning/monitoring studies for data generation programmes, auditing etc as part of the above)
• To represent client companies with regulatory authorities
• To keep updated on new developments in regulatory affairs in relevant areas and advise senior management on opportunities for business development
Skills:
• Excellent technical knowledge in specific area of expertise
• Aptitude for problem solving
• Excellent communication skills, both written and oral
• Excellent computer skills
• Excellent technical writing and report writing skills
• Ability to deliver results under pressure
• Management and motivational skills
• Ability to work on own initiative and as part of a team
• Ability to prioritise workload is essential
• Resilience
Experience:
• Scientific third level qualification
• Minimum 5 -10 years work experience within a science field
If you would like to discuss your current situation or would like further information on our processes then please contact:
Brian Christensen BSc(Hons) HDip on +353 1 685 4747 or email brian.c@lifescience.ie
Life Science Recruitment | www.lifescience.ie
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