Senior Regulatory Affairs Officer
2 days left
- Experience Level
- Experienced (non-manager)
My client, a pharmaceutical Company based in South Dublin now have a vacancy for Senior regulatory affairs officer. This role reports to the director of regulatory affairs.
Review current registration dossier for all marketed products to identify and record dossier completeness, formatting issues, compliance with guidelines / legislation, on-going regulatory issues (pending variations) and outstanding regulatory commitments.
Ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU and international standards
Managing and coordinating various regulatory activities throughout the life cycle of the project / product.
Maintain assigned products’ Marketing Authorisations via timely variations and renewals submissions and their approvals
Ensure meeting registration timelines, via timely response to queries from Health Authorities’ and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, where required.
To contact and liaise directly with Regulatory Agencies as required.
Provide project-specific Regulatory Strategic advice, technical expertise and coordination oversight for assigned projects.
Direct / mentor other RA individuals assigned to support projects of responsibility, as appropriate.
Participate in project launch meetings, review meetings and project team meetings as required.
Share up-to-date legislation and guidance with RA colleagues as appropriate.
Build departmental awareness of local regulatory requirements in EU and international markets and provide regulatory advice, guidance and support to all project teams, as required.
Education & Experience
• Bachelor’s Degree in Pharmaceutical discipline with 5+ years of experience in quality and regulatory teams within cosmetic and pharmaceutical manufacturing facilities
Knowledge, Skills and Abilities
• Attention to detail and quality of documentation
• Good interpersonal skills
• Familiar with computers and their applications, eg. Word, Excel, Power Point
• Effective oral and written communication skills in English language as well as local language where applicable
• Basic organizational and planning skills
• Good negotiation skills
• Ability to work independently with direction
For more information and full job spec please contact Tina on +353 1 2784701 or email your CV to firstname.lastname@example.org
Thornshaw Scientific is a division of the CPL group. www.thornshaw.com
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