Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
- 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.
Job Requirements
Qualifications
- 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
Technical/Functional Skills Required:
- Excellent oral & written communication skills in English.
- Experience of working in matrix organization.
- Agility to work with people from different cultural, economic and political backgrounds.
Core Competencies Required:
- People management skills.
- Regulatory experience in label management in Emerging Markets of the Middle, Near East and Sub-Saharan countries of Ghana, Kenya and Nigeria.
