Senior Regulatory Affairs Specialist

Responsibilities:

• Prepare, review, and submit regulatory documents to regulatory authorities (e.g., NAFDAC) in accordance with applicable guidelines and timelines.
• Conduct peer reviews, QC checks, and document verification as appropriate for documents prepared by other professionals.
• Maintain up-to-date knowledge of local and international regulatory requirements and ensure internal processes align with current standards.
• Support clinical trial applications, amendments, progress reports, and study closures.
• Liaise with regulatory agencies and respond to queries or requests for additional information.
• Collaborate with cross-functional teams, including clinical operations, quality assurance, and pharmacovigilance.
• Ensure proper documentation and archiving of regulatory submissions and correspondence.
• Assist in the development and maintenance of regulatory SOPs and templates.
• Monitor regulatory changes, assess impact on current trials and communicate relevant updates to internal stakeholders.
• Contribute to the company's overall mission to improve patient outcomes and drive innovation in the healthcare and life sciences industry

Requirements:

• B. Pharm or MSc in a related degree
• Good understanding of clinical trials and ICH-GCP guidelines
• 1-2 years of similar regulatory experience in a CRO, regulatory authority or pharmaceutical industry. 
• Good understanding of regulatory processes and documentation standards. 
• Excellent written and verbal communication skills. 
• Attention to detail and ability to manage multiple priorities.
• Proficiency in Microsoft Office and regulatory submission platforms. 
• Ability to work independently and as part of a team.
• GCP certification will be preferred
• Experience with NAFDAC submissions and clinical trial regulations will be preferred