RA Associate - Regulatory Affairs at CDL Human Resource

CDL was founded in early 2003 by its current Managing Director Lucy Mmari.Within her 14 year tenure in a well established logistics company, She honed her skill in human resources management and thereafter started CDL.

 

RA Associate - Regulatory Affairs

  • Job TypeFull Time
  • QualificationBA/BSc/HND
  • Experience1 - 3 years
  • LocationNairobi
  • Job FieldPharmaceutical 

Job Purpose:

  • Support product registration, approvals, and regulatory maintenance activities.
  • Ensure compliance with regulatory standards across operations, production, marketing, quality assurance, and patient safety.
  • Provide technical, scientific, and marketing expertise.
  • Monitor and communicate regulatory updates to facilitate strategic planning and compliance.

Key Responsibilities:

  • Assist with submissions and approvals for new products, variations, clinical trials, and renewals.
  • Conduct due diligence on regulatory documents and ensure timely applications.
  • Maintain strong relationships with internal teams and external stakeholders.
  • Monitor and share regulatory requirements and intelligence.
  • Update and maintain regulatory databases and dashboards.
  • Ensure compliance with global and local regulatory processes and KPIs.
  • Provide technical support to Medical, Market Access, Supply Chain, Marketing, and QA teams.
  • Review and approve marketing materials for compliance.
  • Respond promptly to regulatory inquiries and non-compliance issues.

Requirements

  • Key Performance Indicators:
  • Timely submissions and approvals for product registrations and variations.
  • Strong stakeholder relationships and proactive regulatory communication.
  • Compliance with regulatory and organizational standards.

Qualifications:

  • Education: B.Pharm or a degree in life sciences.
  • Experience: 1-3 years in pharmaceutical regulatory affairs, with knowledge of East and Southern Africa regulatory requirements.
  • Skills: Analytical, detail-oriented, organized, strong communication and interpersonal skills.
  • Languages: Fluency in English; Portuguese or French is a plus.

Method of Application

Interested and qualified? Go to CDL Human Resource on cdl.zohorecruit.com to apply

Comments

Post a Comment

Popular posts from this blog

Operations Associate at Kopo Kopo Inc

Kopo Kopo was launched in 2012 where we partnered with Safaricom to bring Lipa na M-Pesa Buy Goods service to small and medium businesses throughout Kenya and, today, we serve thousands of businesses from salons to restaurants to office supply stores, to schools. We have since partnered with other aggregator and mobile money partners with the ultimate goal of helping businesses leverage mobile payments. We are grateful for our unusual journey and look forward to helping our merchants in growing and prosper in the years ahead.   Operations Associate Job Type Full Time Qualification BA/BSc/HND Experience Location Nairobi Job Field Customer Care  Salary Range KSh 50,000 - KSh 100,000/month The Job:   The role will combine aspects of customer service and operations duties. Ultimately, you will be responsible for quickly solving problems for businesses that rely on Kopo Kopo’s technology. You will ensure that Kopo Kopo’s information systems are kept up to date, and will engage...
Read more

Information Communication Technology - 12 Posts at Judiciary of Kenya

The Judiciary is one of the three State organs established under Chapter 10, Article 159 of the Constitution of Kenya. It establishes the Judiciary as an independent custodian of justice in Kenya. Its primary role is to exercise judicial authority given to it, by the people of Kenya. The institution is mandated to deliver justice in line with the Constitut...   Information Communication Technology - 12 Posts Job Type Contract Qualification Diploma Experience Location Nairobi Job Field ICT / Computer  , Internships / Volunteering  Job Description For appointment to an internship position in ICT, a candidate must:  Have a Diploma in any of the following fields: Computer Science, Information Technology, Information and Communication Technology or its equivalent from a recognized institution. Have graduated not earlier than the  year 2022;  Method of Application Interested and qualified? Go to Judiciary of Kenya on jobs.court.go.ke to a...
Read more

Project Director at LVCT Health

LVCT Health is an indigenous Kenyan non-governmental and not-for-profit organization established in 2001. We are driving Kenya towards HIV prevention, with an ultimate goal of reducing HIV infections to zero. We offer integrated HIV services through development of models that are scaled up to the national models. We also carry out sexual and reproductive ...   Project Director Job Type Full Time Qualification MBA/MSc/MA Experience 7 - 10 years Location Kiambu Job Field Medical / Healthcare  Job purpose The Project Director will be responsible for providing overall strategic and technical oversight to the Dhibiti Project in Central region. This includes responsibility for the technical, monitoring and evaluation and financial and operations components of the project. S/he will work closely with the Program Director and other directors/managers to ensure adherence to technical and contractual requirements of the grant, achievement of targets and project alignment to institutiona...
Read more