CyberscopeTV

About the job

We currently have an opportunity for a Regulatory Labeling Compliance Manager to join our talented Global Product Development Regulatory Labeling team. Position Purpose: The Regulatory Labeling Compliance Manager leads and supports the Labeling group and affiliates in the regulatory compliance activities for the entire product life cycle. The Regulatory Labeling department is responsible for developing and maintaining company Core Data Sheet (CDS), for medicinal products, and for guiding and supporting the implementation of CDS at country level. Major Responsibilities and Accountability: 1. Provides compliance advice and support for PDRL and affiliates to ensure that activities are conducted in accordance to internal Roche procedures, international standards and Health Authority regulations. 2.Provides compliance advice and support for Labeling related projects / initiatives (e.g. system or process developments, outsourcing etc.) and related documentation, process description, training and implementation. 3 Support development, implementation and continuous improvement of the labeling processes, tools and systems to ensure compliance. Proactively identify existing and/or potential compliance issues/gaps, evaluate/communicate potential business impact and advise End to End (E2E) Labeling GPO on corrective/preventive actions. 4.Acts as a point of contact for E2E Labeling GPO for audits and inspections related to E2E labeling processes. Coordinates/contribute to preparation and inspection readiness activities, support the evaluation of audit and inspection findings as well as the establishment of action plans together with functional representatives 5 Maintain in-depth knowledge of relevant SOPs, laws, regulations and guidelines relevant to regulatory labeling and cross functional projects that impact PDRL compliance. 6.Maintain knowledge of country specific requirements and legislation that may impact label implementation compliance by establishing affiliate network. 7.Support, as requested, PDR Labeling colleagues, GRL / named Regulatory lead in the implementation of CDS changes into local products labels 8.Proactively review and analyse compliance metrics. Generate Compliance metrics reports to fulfill HA requirement. Build/Contribute to build an effective affiliate support mechanism to drive improved compliance Professional and Technical Requirements *Bachelor's degree or equivalent in life sciences or other relevant fields *Between 2 to 5 years of experience in compliance area *Good understanding of the pharma process and workflows, mainly in Drug Development *Practical knowledge and experience of regulatory labeling *Fluency in written and spoken English Experience, Knowledge and Skills *Strong communication skills and negotiation skills *Proven ability to influence people at different levels within a matrix environment through persuasion and networking *Ability to apply knowledge and experience practically to complex situations *Highly self-motivated and organized; able to lead/contribute initiatives with authority and creativity *Ability to priorities a high volume and varied workload *Ability to manage others within a project/work stream in order to achieve objectives *Work effectively as a team member in a cross-functional team, matrix-based environment

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Welwyn, Hertfordshire,United Kingdom