Company: Regulatory Professionals
Closing Date: 20 Nov 16
Salary (£): On Application
Regulatory Affairs Senior Manager EMEA Surrey. Rate: Up to £75 an hour (some flexibility) Duration: 12 months freelance Regulatory Professionals have been tasked by a global pharmaceutical and market leader within pharma
Regulatory Affairs Senior Manager EMEA
Rate: Up to £75 an hour (some flexibility)
Duration: 12 months freelance
Regulatory Professionals have been tasked by a global pharmaceutical and market leader within pharma, vaccines and consumer health, to source a Senior Regulatory Affairs Manager to operate out of their Surrey complex.
The successful EMEA - Regulatory Affairs Manager, will manage a team of 3 staff and will report into the Director of regulatory Affairs.
The regulatory Manager will be responsible for the execution of new product registration, the maintenance of existing medicinal product licences and regulatory and quality compliance within EMEA Region.
The role interacts with EMEA Regulatory Affairs (RA) groups, EMEA clinical groups, EMEA Medical Safety, Global Clinical and RA, Research and Development, manufacturing and EMEA business leaders.
As an EMEA regulatory Manager, you will be tasked with the below responsibilities:
*Strategic and Operational key Life cycle maintenance of marketing authorisations in the EU, which are approved through the centralised, mutual recognition and decentralised procedures; Driving the business forward with key life cycle enhancements
*Responsible for the preparation and submission and regulatory approval of new marketing authorisation applications within regional EMEA as required. Including liaison and consultancy advice with Middle East, Africa and CIS countries
*Responsible for operational progression of pre-marketing authorisation activities through direct contact with EMA and CHMP committees, as required
*Strategic communication with the EMA to expedite new marketing authorisation approvals and other operational regulatory interventions as required
*Strategic and operational Interaction with Heads of Regulatory Departments in Europe, CIS, Middle East and Africa as required
*Responsible for driving strategic vision projects in the Region, including strategic and operating plans and value model for Regulatory Affairs, by being a full member of the Country Leadership team for RA
*Strategic and Operational contact with Global Clinical and Regulatory Affairs and manufacturing sites, with regards to submissions and approvals of new registration applications including clinical trial activities in EMEA
*Lead and project manage new product registration strategies and activities in co-operation with Global Clinical and Regulatory Affairs and relevant manufacturing sites
*Regulatory intelligence related to the pharmaceutical eye care industry. Monitor developments in EU legislation and guidelines applying to pharmaceutical products in the EU, and implement for products approved in the EU through the centralised, mutual recognition and decentralised procedures
A minimum of 10 years Regulatory Affairs experience
You must have experience dealing with EMEA and/or CIS
You must have experience of New and Maintenance of MAA, New Drug Development, Life Cycle Management
You should have previous exposure to Centralised procedures and Clinical Trial applications.
Keywords: Regulatory, Affairs, Manager, Senior, EMEA, CIS, Middle East, Africa, Europe, EU, Surrey, Berkshire, Hampshire, Middlesex, Buckinghamshire, Clinical, trials, Strategy, Strategic, Registration, Submission, contract, freelance, regulatory intelligence.
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