Responsible for overseeing labelling and packaging regulatory strategy and implementation for Pharma across the Middle, Near East and Sub-Saharan countries of Ghana, Kenya and Nigeria.
Lead the Labelling Centre of Excellence by driving maximum focus on coordination of translations, mock-up and artwork generation and database management and by ensuring LOCs lead “TRACKWISE” change control or other relevant databases and remain compliant at all times.
Duties And Responsibilities
Lead the creation and maintenance of MEWA multi-country shared packs across the Middle, Near East and Sub-Saharan countries of Ghana, Kenya and Nigeria.
Strategic contact to global labelling, Supply Chain, Regulatory affairs Local operating companies, EMEA Regulatory Management Centre, Business Quality, Business Compliance, Emerging Markets Regulatory Affairs Liaisons.
Liaise with other Project managers of any project impacting MEWA multi-country pack.
Advise cross-functional teams on labeling content consistency.
Collaborate with Emerging Markets Regulatory Affairs Liaisons on submission and implementation strategy for any labeling change.
Prioritize safety labeling changes for the MEWA pack to be implemented on timely manner.
Regulatory Labelling Strategy: lead efficient and compliant regulatory submission, approval strategy for existing and new multicounty packs.
Review the submission plan of all changes affecting MEWA pack and make sure that on time execution by Local Operating Companies.
Participate in regulatory labelling implementation and supply chain criticality meetings and ensure they are running regularly and proactive decisions are being made.
Oversee that confirmation letter upon regulatory approval are properly sent to manufacturing plant to avoid any inclusion of unapproved packaging components.
Facilitate discussion with LOCs and Supply Chain if stock is at risk of being out of stock through Supply chain criticality meeting.
Responsible for mitigation activities in case of delay in regulatory approval or implementation timelines.
Oversee that the labelling MEWA tracker is maintained and up to date.
Escalate labelling issues of MEWA multi-country pack to Labelling Implementation Steering Committee.
Keep management apprised of critical issues which may impact the success of the organization.
Oversight of compliance in end to end labelling implementation.
Update of labelling procedure related to the management of MEWA pack across Middle, Near East and Sub-Saharan countries of Ghana, Kenya and Nigeria.
Supervise labelling coordinator, labelling specialist and change control specialist and prioritize the team workload.
Ensure the review of labels likely to result in non-compliance (e.g. misalignments, labelling content deviations)
Ensure that all change control affecting MEWA multi-country pack are managed on timely manner and in compliance with relevant Work Instructions.
Ensure that MEWA labeling CoE provides optimal support to the new product launches with effective planning upfront.
Good understanding of regulatory filing and approval challenges in the Middle, Near East and Sub-Saharan countries of Ghana, Kenya and Nigeria.
Good understanding of End to End Labelling procedures including graphics and artworks
Good understanding of Supply Chain working model Apply for here