OVERVIEW
Reporting:
Directly to Regulatory Affairs Manager – Sub-Sahara Africa with a dotted line reporting to General Manager of Kenya (Santhosh Raghunathan)
Key Responsibilities and deliverables
Product Registration and life cycle
– Work closely with and supports Regulatory Manager for the East Africa division.
– Registration and compilation of information to ensure regulatory compliance of products for pre and post approval activities.
– Work closely with local regulatory consultant for Kenyan Poisons and Pharmacy Board (KPPB) for drug and medical device submissions.
– Assist with registration of products with authority and shipping agents.
– Ensures compliance of Colgate products with the current regulations in across the region.
Regulatory Assessments
– Deliver regulatory assessment/advice as part of overall business planning/strategies.
– Timely communication to the Company on changes in Regulations that impact Colgate.
– Keeps abreast on latest regulatory requirements and developments in GCC countries.
Regulatory Intelligence – Trade Associations
– Builds strong relationship with key competent authorities in the region ie Kenya, Tanzania, Uganda and Ethiopia.
– Become involved in East African Community Association (EAC).
– Comment on draft regulations for each market when applicable.
– Build and maintain working relationship with national and East Africa standard organizations.
Communication
– Communicates regularly with all stakeholders e.g Commercial teams, the Management of Global Regulatory, and across the region on regulatory updates and issues.
– Develops and communicates short, medium and long term regulatory strategy to enhance growth and business performance.
Day to Day responsibilities
– Maintain database with information on registration status of product portfolio.
– Assist RA manager to compile required documents from source countries for submissions, license renewals and annual registrations and maintenance of product registration dossiers for authorities.
– Ensure that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local/regional regulatory requirements, commitments and agreements.
– Forward regulatory submissions to the relevant authority in East Africa for registrations and license renewal.
– Maintain database with information on regulatory requirements per country (ID card).
– Have regular contact with RA Manager to discuss regulatory issues and updates.
– To liaise directly with Regulatory Assistant in India to submit registration and licensing information for community update.
– Continuously update and advise RA manager and Regulatory Assistant (in India) of any changes in regulations.
– Deliver regulatory assessments for the region when needed.
Profile of the Candidates
1. Education
– Master degree in science eg biology, chemistry, pharmacy, and/or
– Commercial background preferably a graduate in commerce/logistics.
2. At least 2-4 year’s exposure working in a compliance and regulatory environment in East Africa.
3. Fluency in spoken and written English. Knowledge of any local East African countries advantageous.
4. Knowledge, understanding and experience in the following legislations and field would be an added value:
– Cosmetics/Home care
– Medical Devices / Medicines/Complimentary medicine
– Disinfectants
– Transport legislation (ADR)
– GMP
5. Experience in dealing with regulatory and government authorities.
6. Experience in cross-functional team work. Teamwork mindset.
7. Ability to work under stress and meet deadlines.
8. Some experience in working with, influencing and commenting on draft regulations advantageous.
9. Work experience in a multi-national environment preferred.
10. Working knowledge of MS office ( Excel/PP)
Required skills:
– A good understanding of registration and regulatory requirements in East Africa.
– Good communicator with excellent interpersonal skills.
– Effective presentation skills.
– Excellent computer skills which includes working on electronic databases and good knowledge of MS office applications.
– Good knowledge and proven application of administration processes and systems.
– Results oriented.
– Able to work independently.
– Excellent prioritization and time management skills.
– Good planning and organizing skills.
– Self-discipline.
– Effective administration skills.
– Must use initiative, be proactive and have good follow-up skills.
– Good attention to detail.
Location
Kenya