Thisrole provides operational support for the implementation within GlobalRegulatory Affairs of the Internal Control Framework (ICF) elements such asrisk assessment, written standards and control, training, management monitoring(MM) and responding to problem (CAPA/CC/deviation management) also supportingregulatory community in internal audits (Independent Business Monitoring (IBM),Independent Assurance/A&A) or external inspections.
WithinGlobal Regulatory Affairs, this role is responsible for assigned activitiese.g. ensuring written processes and procedures (e.g. SOPs, WIs, etc) are inplace with associated training, internal audits (MM) are timely performed,CAPA/deviation/change control related to processes are completed on-time andrelevant KPIs are deployed aligning with Enterprise policies and supporting theoverall compliance and risk assessment in the Global Regulatory AffairsOversight Committee (GROC).
Job Title: Associate Global Regulatory Affairs Compliance
Role type: Contract (12+ Months) Extendable
Report to:Senior Global Manager Regulatory Affairs Compliance
Supportrisk assessment ensuring regulatory strategic risks related to process areidentified,
managed and mitigated/prevented.
Supportthe SOP/Process Committee and/or support/participate in relevant networks (QMS,RD) toensure development and maintenance of written processes and procedures (e.g.SOPs, WIs, etc) within Global Regulatory Affairs, aligned with Enterprise Policies.
Managetraining associated to global processes and procedures (e.g. SOPs, WIs, etc) inGlobal andRegional Regulatory Affairs from dispatch to reporting in the relevant LearningSystem.
Carryout assigned internal assessment (Management Monitoring) of Global RegulatoryAffairs as agreed with Regulatory Management. Identify and escalate opportunitiesfor improvement in Regulatory and Enterprise-wide.
Generatemetrics that promote the value of compliance and, that support the generation,
interpretation and drive of continuous compliance improvement programs forGlobal Regulatory Affairs.
Providerelevant metrics and data into the Global Regulatory Affairs OversightCommittee
(GROC) to support overall compliance and risk assessment.
Maysupport during relevant internal audits and external inspections that impactGlobal
RegulatoryAffairs (with links to the Quality organization).
Minimum Level of Job - Related Experience required:
• 1-4 years’ experience in a RegulatoryAffairs/Quality area
• 1-4 years within consumer healthcare orpharmaceutical company
Minimum Levelof Educationany UG/PG in Life Science degree (or equivalent)