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Regulatory Affairs Manager at
1 week ago
EABX Securities Exchange Nairobi, Kenya Full timeEABX Plc is a regional market organiser established to consolidate the fixed income and money markets in a transparent, responsible and transformative way. EABX Plc is a strategic financial market infrastructure organisation that is positioned to provide market integration throug ...
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Syngenta Nairobi, Kenya Full timeSyngenta is a leading science-based agtech company. We help millions of farmers around the world to grow safe and nutritious food, while taking care of the planet. · Role purpose · Provide regulatory expertise on SYT active substances relevant for EASA business area. · Elaborate ...
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Regulatory Affairs Specialist
1 week ago
Abbott Nairobi, Kenya Full timeJOB SUMMARY · REQUIRED QUALIFICATIONSBachelor's degree (or higher) in a Healthcare or Life sciences' discipline,PREFERRED EXPERIENCE2 years of experience as a regulatory expert within Medical devices or Diagnostics is EssentialExperience with Multiple countries, ideally Tanzania ...
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Sr. Manager, Country Compliance Officer
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Black Pen Recruitment Nairobi, KenyaOur client, a fintech pioneer, is reshaping the financial landscape with a vision to simplify payments for endless possibilities. Since their inception in 2016, they have become a driving force in Africa's fintech space, connecting millions worldwide through secure and seamless d ...
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General Manager
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Academic Quality Assurance Manager at
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Head of Audit
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jobwebkenya Nairobi, Kenya Full timeThe Agricultural Finance Corporation (AFC), a wholly owned Government Development Finance Institution (DFI), was established in 1963 initially as a subsidiary of the Land and Agricultural Bank. In 1969, it was incorporated as a full - fledged financial institution under the Agric ...
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Manager, Actuarial Reserving at
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Jubilee Insurance Nairobi, Kenya Full timeJubilee Insurance was established in August 1937, as the first locally incorporated Insurance Company based in Mombasa in 1937. Jubilee Insurance has spread its sphere of influence throughout the region to become the largest Composite insurer in East Africa, handling Life, Pensio ...
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World Health Organization (WHO) Nairobi, Kenya Full timeThe World Health Organization is a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948, headquartered in Geneva, Switzerland. · Purpose of consultancy · The purpose of the Roster of Experts (ROE) is to pr ...
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Assistant Manager
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Reeds Africa Consult Nairobi, Kenya Full timeReeds Africa consult (RAC) offers a broad scale of Human resource services designed to provide professional supports for the growing needs of today's corporate organizations · Job Summary: · Our client is looking for An ASSISTANT MANAGER - RISK & COMPLIANCE who will be responsibl ...
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Compliance Officer at Minet Kenya
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Staffrite Nairobi Area, Kenya Full timeKey Responsibilities · The Compliance Officer will assist in developing the existing Compliance function at the business, making improvements to the culture of compliance management throughout the organization. · Duties and Responsibilities · Support the Head of the Department to ...
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KCB Group Nairobi, Kenya Full timeABOUT THE COMPANY · KCB Bank Group is East and Central Africa's oldest and largest commercial banking and has through its history set new records becoming the No.1 Bank in the region. · JOB SUMMARY · MINIMUM POSITION QUALIFICATIONS:The preferred candidate will meet the following ...
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Legal & Compliance Manager at
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Associate Director, Medical Writing at
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International AIDS Vaccine Initiative (IAVI) Nairobi, Kenya Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. · Position Summary: · Are you an experienced Medical Writer who is eager to help translate science ...
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Director Legal Services at
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Kiambu County Government Nairobi, Kenya Full timeKiambu County is one of the 47 counties in the Republic of Kenya. It is located in the central region and covers a total area of 2,543.5 Km2 with 476.3 Km2under forest cover according to the 2009 Kenya Population and Housing Census. Kiambu County borders. · DUTIES AND RESPONSIBIL ...
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Manager, Legal Services at
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Eagle HR Consultants Nairobi, Kenya Full timeHR, Payroll & Consulting Solutions People are at the heart of every successful organization. Investing in human capital is one of the smartest moves a business leader can make. But without the right systems to manage and measure your performance, this investment will never truly ...
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Governance Assistant at
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Clovers Management & Training Consultants Ltd Nairobi, Kenya Full timeSuccess in the staffing industry depends on one thing: placing the right person in the right position. How is this accomplished? By knowing one's clients and candidates Since 1978, Clovers Management & Training Consultants Ltd. has worked with thousands of businesses · Responsibi ...
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Manager, Financial Crime Compliance at
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Standard Bank Group Nairobi, Kenya Full timeStandard Bank Group is the largest African banking group by assets offering a full range of banking and related financial services. "Africa is our home, we drive her growth" Our vision is to be the leading financial services organisation in, for and across Africa, delivering exce ...
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Head of Operations – Ferry Company at
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Career Management Centre Nairobi, Kenya Full timePeople - The human face of an organization, are its most cherished and valuable resources. In a world of multiple choices and multi-faceted people, you need someone to provide you with quality services that can cater to all your human resource needs at one go · Overall Job Summar ...
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Data Protection Officer
4 days ago
Ecobank Kenya Nairobi, Kenya Full timeABOUT THE COMPANY · Ecobank Transnational Incorporated (ETI) acquired 75% of EABS Bank on the 16th of June 2008, and the bank consequently changed its name to Ecobank Kenya Limited. · JOB SUMMARY · - · RESPONSIBILITIES · Develop and oversee the bank's data protection policies, pr ...
Director Clinical Trials Regulatory Management at - Nairobi, Kenya - IQVIA
Description
IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical researchPURPOSE
Using broad management discretion, direct, oversee and manage complex, regulatory project(s), ensuring quality deliverables on time and within budget. Ensure that all work is completed in accordance with SOPs, policies and practices.
RESPONSIBILITIES
Building relationships with African regulators and ECs
Engage with regional stakeholders (e.g. African union, Africa Medicine agency, etc.) to discuss harmonisation efforts and support ecosystem shaping activity
Assist with regulatory intelligence gathering and advisory, for both internal and external purposes
Collaborate with global CTRM colleagues to maximise understanding of global process and structure of both external and internal regulatory arena to support harmonisation and development of best practice
Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate.
May act as a regulatory oversight for a key customer. Responsibilities will include agreeing clinical trial regulatory processes, managing escalations and identifying solutions to challenges that are acceptable to IQVIA and the customerMay strategically plan and perform centralised European submissions and facilitate global submissions for complex studies and programs
Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans.
Continually looks for process improvements.May take a leadership role in bid defense strategy and planning, as appropriate
Deliver presentations/training to clients, colleagues and professional bodies, as required
May act as a Project Manager for a stand-alone project.
May act as regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative
May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience
REQUIREMENTS
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good understanding of the regulations, directives and guidance supporting clinical Research and Development
Extensive experience in regulatory and/or technical writing
Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
Excellent ownership and oversight skills
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Strong software and computer skills, including MS Office applications
Possesses an acute awareness of issues out with the business function. Exudes confidence and authority within remit, delivering a positive example to project teams
Remains motivated and enthusiastic in times of change and other pressure situations
Demonstrated ability to seek and apply industry trends within functional areas of expertise; conscientious of marketing opportunities
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science-related discipline or professional equivalent plus at least 10 years relevant experience* including 8 years regulatory experience (*or combination of education, training and experience)
PHYSICAL
REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Travel will be required