Global Regulatory Compliance Specialist
5 days ago
This role offers the opportunity to lead regulatory activities, manage submissions and develop global regulatory strategies.
Main Responsibilities:- Develop regulatory strategies for key projects ensuring compliance with global requirements.
- Manage regulatory submissions including new registrations post-approval changes renewals and technical variations.
- Track regulatory commitments assess risks and provide strategic input on development plans.
- Act as a scientific and technical resource mentoring colleagues and sharing expertise.
- Prepare responses to regulatory authority queries ensuring timely high-quality submissions.
- Stay updated on evolving regulations and assess their impact on existing and future products.
- Collaborate with internal stakeholders across R&D Manufacturing and Regulatory Affairs.
- Engage with regulatory authorities to support marketing authorisation applications.
- Review GMP documents such as change controls deviations and batch manufacturing records.
- Represent the company at industry conferences and regulatory advisory committees.
- Experience: Minimum 5+ years in Regulatory Affairs within the pharmaceutical industry.
- Knowledge: Strong understanding of EU and global regulatory frameworks.
- Skills: Excellent project management communication and stakeholder engagement.
- Education: Degree in Life Sciences Pharmacy or a related discipline.
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Cork, Cork, Ireland Compliance & Risks Full timeJob title: Regulatory Analyst/Specialist with Japanese, Thai or Vietnamese language skillsReports to: Global Regulatory Compliance Team ManagerLocation: Ireland, Home/Office/Hybrid1 Year Fixed Term ContractOverview of RoleThe GRCT is responsible for monitoring global regulatory developments across a wide range of topics, from Product Safety to WEEE, RoHS,...
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Cork, Cork, Ireland Compliance & Risks Full timeJob title: Regulatory Analyst/Specialist with Japanese, Thai or Vietnamese language skillsReports to: Global Regulatory Compliance Team ManagerLocation: Ireland, Home/Office/Hybrid1 Year Fixed Term ContractOverview of RoleThe GRCT is responsible for monitoring global regulatory developments across a wide range of topics, from Product Safety to WEEE, RoHS,...
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