Overview
Local Territory Representative (LTR) Oversight Specialist | Integrated Commercial Solutions (ICS) Jobs in Nairobi County, Kenya at DP World
Title: Local Territory Representative (LTR) Oversight Specialist | Integrated Commercial Solutions (ICS)
Company: DP World
Location: Nairobi County, Kenya
Job Context
- Regulatory point of contact for processes with the Regulatory Authorities on behalf of Principal companies, corporate strategy and sales teams and other stakeholders to support market access
- Ensure compliance with the regulatory requirements for all the Meditech and Consumer products through the product lifecycle
- Part of the regulatory intelligence, filing strategy and policy requirements team for Meditech and Consumer Healthcare product
Key Performance Areas (KPAs)
- Handle all regulatory authority related activities including registration, variations, retention and renewal of meditech and consumer products in the assigned regions
- Create, develop and implement the regional regulatory affairs procedures for marketed products, new products and maintain updated company regulatory compliance status
- Lead the communication on the requirement of submission, review, approve and maintain technical documents and submissions by articulating and executing agreed strategies for assigned corporate projects
- Act as the regulatory expert within developing projects and ensure regulatory requirements are integrated throughout while maintaining an agile database that is accurate and complete ensuring prompt and accurate access to company regulatory information
- Coordinate and oversee multiple projects, priorities and submission timelines while maintaining long-term view of the project and provide regular regulatory status reports
- Support inspections, audits, post-market activities and continuous improvements
- Ensure compliance to all Health and Safety Requirements of the product are in compliance with International Standards.
- Experienced, driven regulatory lead to bring on board the regulatory expertise, project coordination and collaboration across the Meditech and Consumer health portfolio
- Office documentation, strong IT, problem solving, analytical and communication skills
Qualifications Required
- Bachelor of Pharmacy/Diploma in pharmaceutical Technology or related field
Skills and Experience Required
- Minimum 2-5 years of medical device regulatory experience
- Strong organizational & analytical skills and aptitude for details while managing multiple, competing priorities and deadlines
- Ability to operate in a business-driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.
- Good knowledge of legislative and other standard documents in the sphere of registration and certification of Meditech products (Medical Devices, IVD, Medical Software) and understand industry developments and changes in the environment
- Capability to interact effectively and credibly with senior levels, work effectively alone or as part of a team, manage time and complete tasks with general supervision.
- Ability to represent the interests of the company effectively to a range of regulatory agencies and government officials
About DP World
Trade is the lifeblood of the global economy, creating opportunities and improving the quality of life for people around the world. DP World exists to make the world’s trade flow better, changing what’s possible for the customers and communities we serve globally.
With a dedicated, diverse and professional team of more than 111,000 employees from 159 nationalities, spanning 77 countries on six continents, DP World is pushing trade further and faster towards a seamless supply chain that’s fit for the future.
We’re rapidly transforming and integrating our businesses – Ports and Terminals, Marine Services, Logistics and Technology – and uniting our global infrastructure with local expertise to create stronger, more efficient end-to-end supply chain solutions that can change the way the world trades.
What’s more, we’re reshaping the future by investing in innovation. From intelligent delivery systems to automated warehouse stacking, we’re at the cutting edge of disruptive technology, pushing the sector towards better ways to trade, minimising disruptions from the factory floor to the customer’s door.
DP World is on a mission to transcend boundaries and bridge the gap between all nations and cultures – not just in what we do but also in how we behave.
We are dedicated to creating a culture where everyone feels respected, supported, and empowered to reach their full potential. We believe that embracing inclusion and diversity, drives innovation and growth and helps us connect people, businesses, and societies. Free minds and different perspectives are changing our world, and together we can change what’s possible.
WE MAKE TRADE FLOW TO CHANGE WHAT’S POSSIBLE FOR EVERYONE.
EEO Statement
DP World is committed to the principles of Equal Employment Opportunity (EEO). We strongly believe that employing a diverse workforce is central to our success and we make recruiting decisions based on your experience and skills. We welcome applications from all members of society irrespective of age, gender, disability, race, religion, or belief.
By submitting your resume and application information, you authorize DP World to transmit and store your information in the world-wide recruitment database, and to circulate that information as necessary for the purpose of evaluating your qualifications for this or other job vacancies.
