Regulatory Affairs Associate II

Who we are

The opportunity

• 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.

How you’ll spend your day

• 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

Your experience and qualifications

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

Relationships

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

Reports To

Associate Director, Senior Manager or Manager Regulatory Affairs

Teva’s Equal Employment Opportunity Commitment