Regulatory Affairs Associate II

Who we are

The opportunity

The role of the RIM team is to:

• Develop and implement the RA business systems strategy required to ensure that Global Regulatory Affairs (GRA) systems continue to meet ongoing and emerging business needs.
• Provide the expert business analysis input required for the successful development of strategic system roadmaps and for the successful implementation of the projects required to ensure the delivery of the technology solutions required to support the GRA business and its partner functions.
• Provide RA Business Data Administration and Business System Ownership, including system and data related business change management, in support of the RA business process and data requirements, and compliant system usage.
• Partner with external pharmaceutical industry stakeholders (e.g. industry associations) and health authorities to influence outcomes relating to emerging requirements such as ISO IDMP and FMD etc.
• Manage and deliver the Teva XEVMPD submissions related to Investigational Medicinal Products, review and remediate Authorized Medicinal Products 3rd acknowledgment and EMA follow up reports to ensure Article 57 compliance.
• Support PV in case of audits and inspections, provide Teva XEVMPD records EV web reports, review and/or remediate the Teva xevmpd records (if required) including collaboration on CAPA plan in case any finding is related to RIM/xevmpd data
• Support the in-house Regulatory Data Administration team for the management of Teva registration data. This includes support for data integration and data integrity/enrichment initiatives to ensure compliant and reliable RA data for accurate reporting and business decisions making.

How you’ll spend your day

The RIM Business Analyst/Project Manager will support and enable the successful execution of this role.

• Responsible for supporting effective business project management for regional and global projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data and documents or the regulatory technology landscape.
• Required to lead cross-regional and cross-functional projects teams, working and influencing staff at all levels within the organization to ensure regulatory systems, and related processes, are developed and enhanced to meet the diverse regulatory business process and data requirements.

The RIM Business Analyst/Project Manager will work closely with the Harlow based RIM and GRO Regulatory Data Administration teams. Will work closely with the GRA functional teams dependent upon these operations. Will act as change manager, and/or escalation point for these operations to ensure their continued effectiveness, and to ensure GRA business needs continue to be met by these operations.

• They will be an effective Business Analyst, responsible for deep dives in to current and mapping future business process, be expert in interrogating regulatory legislative and guidance documents and draw on that expertise to shape the to-be processes to ensure business compliance.
• Responsible for providing effective Business Data Administration oversight for GRA data (e.g. for the data management/data quality decisions that impact system dictionary-controlled values and for defining, obtaining agreement to, and communicating, GRA data process related work instructions etc.)
• Must be fluent with Pharmaceutical Regulatory Affairs business processes.
• Must leverage deep regulatory business expertise to successfully partner with Regulatory Affairs functional/strategy teams, and IT etc.
• Must understand evolving regulatory requirements and guidelines.
• Must be able to understand and define new RA business requirements, translate those into strategic project proposals for change and to deliver those projects.
• Must be analytical, methodical, and able to successfully analyse data, process, and external regulatory requirements.
• Must be a highly effective communicator, capable of relaying complex concepts to all levels and functions of the company.

Your experience and qualifications

Qualfication:

• Required: Bachelor’s Degree in Life Sciences or Information Technology
• Preferred: MS in scientific or information technology discipline

Experience:

Required:

• 3 to 5 demonstrable experiences of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Demonstrable experience of leading cross-functional project teams and change projects, including working within a multifunctional/geographical matrix.
• Demonstrable experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing RA business data demands.

Preferred:

• Extensive experience of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Extensive experience of leading cross functional project teams and change projects, including working within a multifunctional and geographical matrix.
• Extensive experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing business process data demands.
• Experience with Parexel/Liquent’s Insight/Veeva regulatory information management suite of products. 

Specialised/ Functional/ Industry knowledge required

• Knowledge of global (FDA, EMA, Health Canada and Japan) regulatory requirements.
• Knowledge of global industry initiatives and direction.
• Knowledge of industry regulatory standards (eCTD, CDISC, EVPRM, SPL, ISO IDMP, SPOR, RIM systems etc).
• Understanding of regulatory business processes: regulatory submission, CMC, product strategy, registration/regulatory data management..
• Understanding of the drug development process for generics, branded, and Non-Med product development a plus.
• Working knowledge of system and business process design and implementation a plus.

Reports To

Sr Manager, RIM, Global Regulatory Operations

Teva’s Equal Employment Opportunity Commitment