Regulatory Labelling Compliance Manager
- Interim/Contract
- Regulatory Affairs, Labelling
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Hobson Prior are looking for a Regulatory Labelling Compliance Manager to join a multinational healthcare company at their offices in Hertfordshire. This position will lead and support the Labelling group and affiliates in the regulatory compliance activities for the entire product life cycle.
Job Responsibilities:
- Accountable to provide compliance advice and support for PDRL and affiliates to ensure that activities are conducted in accordance to internal procedures, international standards and Health Authority regulations.
- Provides compliance advice and support for Labeling related projects / initiatives and related documentation, process description, training and implementation.
- Represent as a point of contact for E2E Labeling GPO for audits and inspections related to E2E labeling processes.
- Support development, implementation and continuous improvement of the labelling 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.
- 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.
- Maintain in-depth knowledge of relevant SOPs, laws, regulations and guidelines relevant to regulatory labelling and cross functional projects that impact PDRL compliance.
- Maintain knowledge of country specific requirements and legislation that may impact label implementation compliance by establishing affiliate network.
- Support, as requested, PDR Labelling colleagues, GRL / named Regulatory lead in the implementation of CDS changes into local products labels.
- Proactively review and analyse compliance metrics. Generate Compliance metrics reports to fulfil HA requirement. Build/Contribute to build an effective affiliate support mechanism to drive improved compliance.
- Support members of PDRL, as requested, to train other PDRL staff, Program and Product teams, DRA affiliates on labelling policies and procedures.
Key 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.
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 labelling.
- Fluency in written and spoken English.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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