Regulatory Affairs Head, English West Africa at Novartis Nigeria

Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines

We are recruiting to fill the position below:

Job Title: Regulatory Affairs Head, English West Africa

Ref Id: 308121BR
Location: Lagos
Division: Global Drug Development
Business Unit: REG AFFAIRS GDD
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No

Job Description

• Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
• Partners with regions to align on regulatory strategy in order 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 GTAL.
• Facilitates preparation and finalization of briefing books and contributes to 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, approves and submits 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 GTAL.
• 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 the development of departmental goals and objectives.

Minimum Requirements
Educational Qualification:

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

Required Experience:

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

Application Closing Date
Not Specified.