Our Client
A reputable multinational Pharmaceutical Company in Nigeria is seeking a qualified, experienced and dedicated individual to fill the position of a Drug Regulatory Affairs (DRA) Head.
Job Profile
Efficient management of regulatory matters in the assigned country group, ensuring registration milestones of global and regional/local projects are met and in line with business and functional objectives. Successful maintenance of existing licences. Input to regulatory strategies aligned with commercial and Regional objectives. Regulatory functional excellence, including all compliance related activities are achieved and maintained.
Main Responsibilities and Duties
New registrations and approvals
Licence maintenance
Local /Global Database (or similar) maintenance
DRA Compliance
Packaging materials: owner of local packages
Promotional material validation and approval
Leadership and Management of Direct Reports (where applicable)
Regulatory Intelligence-managing the regulatory environment
Business awareness e.g.: applies business and commercial basic principles to effectively support proposed regulatory strategies and Portfolio plans.
DRA Budget of assigned cluster
Key Performances
Management of Development Portfolio plans with regular and timely communication of performance, and issues. Update of Portfolio development plans, or input into DASA tool.
Achievement of standard and stretch registration milestones/deliverables.
Time to market of new launches with competitive labelling.
Completeness/accuracy of the cluster Standard Requirements and timely communication to HQs on significant changes.
Effective management and proactive communication of emerging regulatory changes with impact to the assigned cluster/countries to respective local and global stakeholders.
Ability to drive and propose changes on regulatory emerging regulations with successful outcome to the Organization.
Successful stakeholder management (internal and external)
Successful people development and talent retention
Adequate budget management and planning
DRA functional excellence and submission strategies
Achievement of Regulatory compliance deliverables as per global target
Qualification & Experience
Doctorate of State in Pharmacy or similar degree in Life Science
English (Fluent), other languages such as French is desired but not mandatory
Minimum of 6 years’ experience in Drug Regulatory Affairs, preferable at al Pharmaceutical Industry or equivalent
Experienced leader proven successful management of people
Excellent communication and negotiation skills
Strong result driven, ability to bring innovative ideas, “think out of the box”
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