Emmanuel Amadi
Regulatory Affairs Specialist @阿斯利康
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WORK HISTORY
Regulatory Affairs Specialist @阿斯利康
London, GB
Ensure timely submission and approvals of all licensing applications and compliance with UK regulatory requirements• Assure appropriate standards and policies are maintained for all technical aspects of the company’s regulatory activities are adhered to• Provide regulatory input to stock and supply issues whilst liaising with Operations to manage pack changes and ensure labelling compliance• Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling• Develop professional working relationships with assessors and administrative staff within the regulatory agencies• Prepare high quality regulatory applications and regulatory responses for UK• Actively contribute to cross-functional team working within the Medical & Regulatory Department and other areas of the business• Support the delivery of commercial objectives, including representing Regulatory Affairs on appropriate cross-functional teams• Ensure Prescribing Information is in accordance with the licence• Provide regulatory input relating to commercial brands, including competitor intelligence• Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues• Ensure appropriate cross functional input into the delivery of optimal licence strategies• Identification of regulatory strategies to support commercial and business objectives and company efficiencies• Plan and execute the workload for defined product responsibilities in consultation with the Regulatory Affairs Lead• Proactively manage the regulatory process for clinical trials for UK
EDUCATION
University of Hertfordshire
BSc Pharmacology
SKILLS
ABOUT EMMANUEL AMADI
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.I have 7 years experience in the Pharmaceutical industry plus 6 years experience within this Health Authority as an Accredited Scientific Assessor.
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