Senior Regulatory Affairs Specialist

About the job

We are hiring several regulatory lead roles and looking for contributors who are fully proficient in applying regulatory knowledge and can work with high sense of ownership under limited supervision.

Essential Functions:

• Act as a Regional Regulatory Team Lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level in Sub Sahara region (Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Congo, Ethiopia, Gabon, Ghana, Guinea, Ivory Coast (Cote D Ivoire), Kenya, Madagascar, Mali, Mauritania, Mauritius, Niger, Nigeria, Senegal, Togo, Zambia).
• Act as client’ representative in front of health authorities and with different client partners (Agents/distributes) in several countries.
• Prepare, review and submit regulatory documentation (for example: CTD-e-CTD submissions), as appropriate; follow through post approval commitments.
• Establish strong relationships with stakeholders; present regulatory projects and progress, discuss issues and customer comments.
• Act as an Subject matter expert implementing Regulatory knowledge in Quality/ Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing/ Change assessments; or as applicable.
• Up to date with regulatory intelligence information in different health authorities, communicating to clients and working groups to define best strategy and anticipate future trends.
• Understands the Scope of Work, deliverables and management of budget for several given projects and manages workload as appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training/ development/on-boarding and internships.
• Present to clients on complex regulatory processes at large full service bid defense meetings.
• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
• Performs other tasks or assignments, as delegated by Regulatory management.
  

Qualifications:

• Degree in Life science or related discipline is a must. Professional post graduate degree is a plus.
• High English proficiency, French proficiency is a plus.
• At least 3-4 years relevant experience in regulatory national and/or regional scope of work.
• Good understanding of the regulations and related guidelines in Egypt, gulf, levant and north Africa region.
• Good understanding of Regulations (Pharmaceutical, OTC, Medtech and Biological is a must).
• Good knowledge of different regulatory dossiers: CTD, e-CTD, NeeS is a must.
• Possesses a specific regulatory or technical expertise.
• Good, solid interpersonal communication and organisation skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable.
• Demonstrates self-motivation and enthusiasm; high sense of ownership.