Regulatory Affairs Associate II

• To perform the necessary regulatory tasks to help obtain new Marketing Authorisations and maintain the existing licence portfolio in the UK/IE.
• To follow regulatory guidance and Teva procedures to ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment.
• Work in conjunction with line manager to give regulatory support to project teams, stakeholders and customers, as required.

• With support from Line Manager prepare, compile, review and submit appropriate high quality post-approval changes (variations, renewals, PIQU submissions) and responses to Health Authority questions in accordance with in-house standards and current legislation.
• Provide administrative support for new Marketing Authorisation Applications for UK (GB/NI)
• Provide national support for EU variations / new marketing applications in line with deadlines set by the requestor and in accordance with in-house standards and current legislation.
• Ensure approvals are secured within the stipulated timelines for designated products and projects.
• Maintain registration documentation and associated electronic databases, in line with Teva s processes and procedures as outlined in the relevant SOP s and WI s.
• Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
• To work closely with Line Manager to prioritise, plan and monitor allocated projects against defined timelines.
• Maintain and develop awareness of current/pending regulatory legislation and guidelines
• General support activities for the UK/IERA team including support for Teva s finance system (raising PO s and approving invoices)
• Other duties as required at the direction of senior Regulatory Affairs personnel.

Major Job Challenge(s):

• Supporting a large and diverse licence estate.
• Meeting specific objectives whilst addressing frequent and often unscheduled issues and changing priorities.
• Developing an understanding of, and familiarity with, the complicated system of regulation and control of medicinal products and adapting to the rapid changes in this area

Qualifications and Experience:

• M. Pharma with 4 7 Years of experience in relevant pharmaceutical field.

Knowledge:

• Desirable to have UK, IE or other EU member state experience and knowledge of regulatory procedures
• Basic understanding of processes and departments within a pharmaceutical company

Skills:

• Excellent oral and written communication
• Ability to work under pressure and to tight time deadlines
• Effective time and organisation management
• Being able to work under own Initiative
• Analytical thinker (data rational)
• Computer literacy

Internal:

• All personnel within UK/IE Regulatory Affairs
• EU Regulatory Affairs
• Manufacturing, Packaging, QC testing and QA release sites
• Portfolio and Project Management
• Business Development
• Product marketing and management
• Supply Chain and EPD
• Medical Affairs, Medical Information and Pharmacovigilance
• Customer Sales Marketing
• Procurement
• Artwork Generation Groups

External:

• MHRA
• HPRA
• Customers
• Suppliers

Associate Director, Senior Manager or Manager Regulatory Affairs