Experience

Catalyst Global

• United States
• Non-profit Organization Management
• 1 - 100 Employee

• Regional Manager for Regulatory Affairs and Programmes

  • Jan 2021 - Present



Catalyst Global

• United States
• Non-profit Organization Management
• 1 - 100 Employee

• Senior, Global Regulatory Affairs Specialist

  • Jan 2017 - Dec 2019

• Global Regulatory Affairs Specialist

  • Oct 2014 - Jan 2017

  Position Summary:Reports to the Director of Regulatory Affairs Department. Primary liaison for the Woman Care global and USAID projects (EECO) in the African region. Responsible for the assessment and gathering of documentation required by the Regulatory Authorities in the African region for the successful registration and maintenance of regulatory applications.PRINCIPAL ACTIVITIES PERFORMED:Responsible for the regulatory landscape assessment and meet with local stakeholders to support the registration activities in the USAID project countries.Responsible for the compilation, regulatory accuracy, and completeness, of the documentation required by the Regulatory Authorities.Prepare or maintain technical files or dossier as necessary to obtain and sustain product approval. Identify relevant guidance documents, standards, or consensus standards and provide interpretiveassistance. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.Reviews technical documents for regulatory compliance, and comments as necessary.Write or update standard operating procedures, work instructions, or policies as necessary. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.Interpret regulatory rules or rule changes and ensure that they are communicated throughcorporate policies and procedures.Compile and maintain regulatory database updated and well organized. Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical and Regulatory Associate

  • Nov 2011 - Oct 2014

  Regulatory Affairs functions: - Worked with the Regulatory Affairs Manager to ensure efficient renewal, variation approval process for products and indications in line with the local business strategic plan; provide clear, accurate and on-time information to authorities, in order to ensure rapid and successful authorisation. - Ensure that all regulatory dossiers are maintained and updated to the highest professional standards, ensuring that Sanofi Pasteur confirms to all legal and ethical requirements in the country. - Ensure proper document retention / archiving of all Regulatory documents. - Update Global Database with any new / changed information to ensure that information is current. - Liaise with Regulatory Affairs, Sales and Marketing from Sanofi Pasteur RSA, and RA at Headquarters (France), to plan registration, renewal and variation activities around the strategies that have been chosen as part of the strategic planning and business plan exercises. - To ensure that all product labelling complies with the Regulatory Authorities’ requirements in South Africa and SADC countries where products are marketed and those of Sanofi Pasteur HQ with regard to safety and efficacy of the products. Medical (Pharmacovilance) functions: - Ensure that AEs are reported within 24hours by monitoring the PV inbox on a daily basis. - Ensure that reports are followed up until closure through collaboration on a daily basis with the LPO. - Ensure that the tracking log is completed on a daily basis and appropriate time bound CIOMS reports are faxed to NADMC. - Maintain a pharmacovigilance filling and tracking system on a daily basis. - Reconcile AEs as defined by the SOPs and contractual agreements. - Update SOP as required. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate Trainee

  • Jan 2011 - Aug 2011

  Site initiation Site selection Monitoring Site close out Report writing Site initiation Site selection Monitoring Site close out Report writing