RA Associate - Regulatory Affairs
RA Associate - Regulatory Affairs
Posted on :
08-01-2025
Employer Active
1 Vacancy
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Job Description
Job Title: RA Associate Regulatory Affairs
Location: Nairobi
Industry: Pharmaceutical
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 noncompliance 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: 13 years in pharmaceutical regulatory affairs with knowledge of East and Southern Africa regulatory requirements.
Skills: Analytical detailoriented organized strong communication and interpersonal skills.
Languages: Fluency in English; Portuguese or French is a plus.
Employment Type
Full Time
Key Skills
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