Senior Regulatory Affairs Associate - Pharma
Job Summary: Owing to expansion and internal promotion within our EMEA Regulatory Affairs Team, we have an opportunity for Senior Regulatory Affairs Associate to join Hospira. This is an ideal opportunity for an experienced Regulatory Affairs Associate who is keen to further progress their career. Primary Purpose: To obtain and maintain Marketing Approvals (Product Licenses) in territories administered by Hospira UK regional office. Major Functions: Project management of European (MRP, Centralised, NCE) and World-wide regulatory projects. Preparing registration strategies as appropriate. Provide advice and determine appropriate action for proposed manufacturing/license changes. Preparing and submitting product license applications. Preparing and submitting variations to approved product licenses. Preparing and submitting applications to renew product licenses as necessary. Ensuring compliance with new regulatory requirements, as they are issued/updated by the regulatory authorities. Responding to requests for technical support from regional offices and local distributors as required. Reviewing production changes against registered information throughout EMEA region, to allow batch release. Ensuring all internal documentation is compliant with registered particulars. Maintenance of databases relating to regulatory activities. Liaise with Regulatory Agencies. Liaise with labelling group to generate appropriate packaging materials. Liaise with medical support group and take appropriate action in relation to pharmacovigilence. Additional Functions: Provide guidance/support to Regulatory Affairs Associates. Deputise for the Manager as necessary. Responsible for keeping colleagues informed on regulatory matters associated with an assigned group of products. Participate in project teams (may involve activities related to the submission of clinical trial applications) as required. Person Specification: Essential: Degree in Pharmacy or Life sciences. An organised and systematic approach to work with good time management skills. Analytical skills. Creative thinking – to determine the best approach to obtaining approvals. Ability to work well individually and as part of a team. Proactive approach with high personal energy. Good communication skills – ability to communicate plans/ideas/information across to managers (both UK and regional) and regulatory agencies. Previous experience of similar regulatory work – preferably 3 years or more. This is a contract role which will run for a minimum of 18 months. In return you will receive an opportunity to work autonomously on a variety of products across multiple markets. Excellent remuneration on offer. Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™ through the right people and the right products. Through its products, Hospira helps improve the safety, cost and productivity of patient care. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Hospira is also a leading provider of contract manufacturing services to proprietary pharmaceutical and biotechnology companies for formulation development, filling and finishing of injectable pharmaceuticals. Its broad portfolio of products is used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. Through its offering of high-quality, lower-cost alternatives to proprietary medications, Hospira continues to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system. The company also is a pioneer in providing innovative solutions to improve patient and healthcare worker safety. By working with its customers to integrate technologies at the point of care, Hospira is the partner of choice for improving patient and workplace safety, clinical outcomes and cost management, and caregiver efficiency and effectiveness. The name "Hospira" is derived from the words hospital, spirit, inspire and the Latin word spero, which means hope. It reflects the company's primary market focus and expresses the hope and optimism that are critical in the healthcare industry. Please visit www.hospira.co.uk for more information
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