Amiee Allen
Regulatory Affairs Manager, Emea @Colorcon®
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WORK HISTORY
Regulatory Affairs Manager, Emea @Colorcon®
Dartford, GB
Manage regional assigned regulatory requests via Colorcon’s Customer Support Solution within expected timeframes- Work collaboratively with internal departments to coordinate customer responses- Represent Colorcon at external events- Promote continuous improvement within the department and provide support to other departments- Provide training, coaching and support to staff in activities relating to areas of responsibility- Ensure records generated by the Regulatory Affairs Group are accurate and generated in accordance with company SOPs- Manage Quality/Regulatory Questionnaires to provide an efficient and complete response to the customer- Communicate directly with customers and regulatory agency personnel regarding regulatory requests or questions- Advise the Site Leadership Team in matters with regulatory implications- Collaborate with other sites globally to adopt best practices- Accountable for resourcing projects requiring regulatory representation as requested.
EDUCATION
University of Greenwich
Healthcare Management MSc, Healthcare Management
Cirencester College
Biology, General
Arden University
Executive MBA, Business Administration and Management, General
University of Kent
Biomedical Science, Biology/Biological Sciences, General
The Manchester Metropolitan University
Postgraduate Degree, Health Professions and Related Clinical Sciences, Other
Sir William Romneys
GCSEs
ABOUT AMIEE ALLEN
Regulatory Affairs Professional | Clinical, Pharmaceutical & Dietary Sectors | EU Regulatory Submissions & ComplianceStrong background in regulatory affairs, specialising in preparing and managing successful regulatory submissions, including new Marketing Authorisation Applications (MAAs) and post-approval variations in the EU region. My expertise spans the entire drug development lifecycle, from early-stage strategy to post-marketing compliance.I have experience liaising with key regulatory agencies, including the MHRA, and HPRA, ensuring approvals and compliance. Passionate about advancing healthcare innovation, I enjoy staying at the forefront of evolving regulations.Certifications & Professional Affiliations:RSci | BSc (Hons)| MSc | PGCert | LIBMS | TOPRAQualifications & Achievements: MSc (Distinction) in Healthcare Management – University of Greenwich (2022)Study involved comparison of blood gas analysis with conventional automated laboratory-based methods, addressing service demands and supply chain disruptions in Great Britain, as a result of the Covid pandemic BSc (Hons) in Biomedical Science (First-Class, IBMS-accredited) – University of KentCompleted a Sandwich Year and registered with HCPC as a Biomedical Scientist in 2017 Significant experience working in major NHS Foundation Trusts Royal Society of Biology \"Top Project Student\" Award (2017) – Presented at the Houses of Parliament
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