# Regulatory Affairs Pharmacist, Business Solutions – Diagnostics

**Company**: IQVIA
**Location**: Nairobi, Kenya
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Nairobi-Kenya/Regulatory-Affairs-Pharmacist--Business-Solutions---Diagnostics_R1579378?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/regulatory-affairs-pharmacist-business-solutions-2368b79d-08c/

## Description

Our client, a global leader in healthcare and diagnostics, is seeking a highly motivated Regulatory Affairs Specialist, Business Solutions – Diagnostics to support regulatory activities across East Africa.

**Key Responsibilities**

**Regulatory Strategy & Market Access**

- Develop and execute regulatory strategies for diagnostic products across East African markets.

- Monitor regulatory changes, legislation, and evolving market requirements.

- Support regulatory advocacy initiatives and engage with health authorities and industry stakeholders.

- Contribute to healthcare policy discussions and regulatory convergence initiatives.

**Registration & Product Lifecycle Management**

- Prepare, compile, and submit regulatory dossiers and registration applications.

- Manage registration approvals, renewals, variations, and product maintenance activities.

- Maintain accurate records of licenses, registrations, approvals, and expiry dates.

- Ensure ongoing compliance of products throughout their lifecycle.

**Commercial & Business Support**

- Provide regulatory support for tenders, technical evaluations, and health technology assessments.

- Support commercial teams, distributors, and business stakeholders on regulatory matters.

- Assist with product launch activities and market entry initiatives.

- Respond to regulatory enquiries from internal and external stakeholders.

**Compliance, Quality & Vigilance**

- Ensure compliance with applicable regulatory, vigilance, post-market surveillance, complaint handling, and recall requirements.

- Support Quality Management System (QMS) activities and regulatory SOP implementation.

- Collaborate with Quality and Safety teams on product-related incident reporting and field actions.

- Support regulatory inspections, audits, and authority interactions.

**Stakeholder Engagement & Training**

- Build strong relationships with regulatory authorities, ministries of health, distributors, and industry associations.

- Deliver regulatory guidance and training to associates, distributors, and business partners.

- Collaborate closely with cross-functional teams including Quality, Medical Affairs, Marketing, Supply Chain, and Commercial functions.

**Minimum Requirements**

**Education**

- Bachelor's Degree in Pharmacy, Life Sciences, Biomedical Sciences or related field.

**Experience**

- Minimum 3 years' Regulatory Affairs experience within Medical Devices, In Vitro Diagnostics (IVD), Diagnostics, Healthcare or Pharmaceutical industries.

- Proven experience managing regulatory submissions and registrations.

- Experience working with East African regulatory authorities and regulatory frameworks.

- Exposure to vigilance, post-market surveillance, and quality systems would be advantageous.

**Knowledge & Skills**

- Strong understanding of medical device and IVD regulatory frameworks across East Africa.

- Knowledge of product registration processes and lifecycle management.

- Understanding of quality management systems and vigilance requirements.

- Excellent communication and stakeholder management skills.

- Strong project management and organizational ability.

- Ability to manage multiple projects and deadlines simultaneously.

- High attention to detail and commitment to compliance.

- Proficiency in Microsoft Office applications and regulatory management systems.

- Fluent English communication skills.

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## Skills

### Required
- regulatory affairs
- medical devices
- IVD
- diagnostics
- healthcare
- pharmaceuticals
- quality management systems
- vigilance
- post-market surveillance
- stakeholder management
- project management
- Microsoft Office

### Nice to have
- East African regulatory authorities
- regulatory frameworks
- product registration processes
- lifecycle management

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Nairobi-Kenya/Regulatory-Affairs-Pharmacist--Business-Solutions---Diagnostics_R1579378?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)