Job SummaryThe Regulatory Affairs Manager role focuses on ensuring regulatory compliance for products in East African markets, both before and after approval. This includes compiling product dossiers for registering any other necessary information, also providing regulatory advice for business planning, and promptly communicating regulatory changes and impact to the organization. The role involve...
The Insurance Regulatory Authority of Kenya (IRA) is the sole authority charged with regulation and supervision of the insurance industry within the Republic of Kenya. It ensures compliance by insurance/reinsurance companies, protects consumers and promotes a high degree of security for policyholders. Duties and responsibilities will entail: Managerial / Supervisory Responsibilities Manage review...
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Review of labels following local HA guidelines and advise customers on the best compliance practices. Perform high-quality CMC review of technical documentation i.e. CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and Labelling documents, for filings with HA. Attend Pre-Submission meetings with the HA and prepare post-meeting package/minutes for internal, client, and HA records. Assist in t...
AstraZeneca is a global, science-led biopharmaceutical company that spans the discovery, development, manufacturing, distribution and worldwide commercialisation of primary care and speciality care medicines. We believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is...
AstraZeneca is a global, science-led biopharmaceutical company that spans the discovery, development, manufacturing, distribution and worldwide commercialisation of primary care and speciality care medicines. We believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is...
Job Overview: Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Prepare site regulatory documents, revie...
Job Description Job Overview: Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Prepare site regulatory ...
Job Purpose To support Bank management in the identification and management of compliance risk as required by relevant regulatory, supervisory and statutory regulations/guidelines, applicable codes of conduct and minimum standards. Update of Compliance Policies and Documentation Updating the regulatory universe and ensuring the compliance risk management plans (CRMPS) for new laws, regulations an...
IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including consulting services. It has a n...
Regulatory and Start Up Specialist IQVIA RSUWork from any location Must speak Dutch and EnglishJoin us on our exciting journey!IQVIA Clinical Functional Services Partnerships (FSP) business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our customers. We set ourselves apart with collaboration and face to face contact both at start up ...
The Insurance Regulatory Authority of Kenya (IRA) is the sole authority charged with regulation and supervision of the insurance industry within the Republic of Kenya. It ensures compliance by insurance/reinsurance companies, protects consumers and promotes a high degree of security for policyholders. REF: MCE/09 Purpose The position is responsible for managing the process of creation awareness a...