Job Description

Regulatory Affairs Head, English West Africa Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions. Partners with regions to align on a regulatory strategy to fulfil business objectives. - Implements RFP across assigned regions.

 

JOB RESPONSIBILITIES

 

• Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.

• Provides input into global regulatory strategy and contributes to the Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in the global strategic plan for assigned regions.

• Partners with regions to align on a regulatory strategy to fulfil business objectives.

• Implements RFP across assigned regions.

• Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTA.

• Facilitates the preparation and finalization of briefing books and contributes to the preparation of summary documents. -Develops and implements plans for timely response to HA requests and coordinates responses.

• May serve as local HA liaison depending on location (e.g., FDA or EMA).

• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.

• Review of global dossier summary documents.

• Develops and implements plans to avoid/minimize clock stops during submission review.

• Reviews approve and submit Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).

• Reviews and submits Risk Management Plans.

• May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTA.

• Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.

• Contributes to and often leads to the development of departmental goals and objectives.
  
  

REQUIRED EXPERIENCE

 

Minimum requirements

• Operations Management and Execution Project Management Representing the organization Functional Breadth Cross-Cultural Experience

 

Educational Qualification

• Pharm D, Master in Life Sciences degree. PhD or Higher Degree or equivalent experience desirable

Skills

Communication

People Management

Planning and organisation skills

Problem-solving ability

Interpersonal Skills

Original Thinker

Intelligent