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 Title: 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.
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”
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
How to Apply
Click Here to Apply
Leave a Reply