- To manage the regulatory department and develop processes so that new chemical entities, new dosage forms and new indications are registered in a timely fashion.
- Overall responsibility for compiling regulatory submissions to NAFDAC and other regulatory bodies, drafting Product Information, Consumer Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PI development, packaging changes, MIMS notification and other regulatory activities.
- Ensure that all state and federal regulatory requirements are addressed for the clinical research programme and for marketed products.
- Develop professional relationships with NAFDAC staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
- Provide regulatory expertise to clinical project teams (CTN applications, importation of clinical trial material, reporting of adverse events).
- Provide regulatory expertise to global product development teams.
- Conduct training sessions for CRAs and sales representatives on ADR reporting and the importance of pharmacovigilance.
- Working with marketing to ensure that the content of all promotional material is fully supported by the Product Information and literature, and in accordance with the guidance offered by NAFDAC and other government regulators.
- Bachelor's Degree in Pharmacy
- The Person MUST have minimum 4 years considerable experience in Superintending and Regulatory affairs in relevant Pharmaceutical industry.
- Regulatory Filings
- Project Management
- Regulatory Filings
- Good knowledge on research, product development and regulatory fields
- Analytical and strategizing abilities
- Capable to manage the entire regulatory department of the organization
- Hiring, training, and monitoring the performance of other personnel
- Proficient use of Office applications, email, social media and other communication tools essential.
- Strategic experience for products and experience of Health Authorities meetings
- Strong attention to details and organizational skills required
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