Senior Regulatory Affairs Associate – Veterinary Sciences
il y a 6 jours
Senior Regulatory Affairs Associate – Veterinary Sciences
Location: Algeria
Employment Type: Full-Time
Seniority Level: Senior
About the Role
We are seeking a highly qualified and experienced Senior Regulatory Affairs Associate to provide regulatory support across the Sub-Saharan African region. This is a senior-level position requiring strong expertise in veterinary sciences and regulatory affairs, with proven experience in stakeholder engagement and compliance management.
Key Responsibilities
- Regulatory Affairs Management
- Oversee regulatory aspects of the company's veterinary portfolio in relevant countries.
- Develop, maintain, and implement plans for new product registrations aligned with business objectives.
- Ensure compliance with local and regional regulatory requirements, including dossier preparation, submission, and follow-up.
- Maintain existing registrations through variations and renewals.
- Stakeholder Engagement
- Collaborate with external partners, NGOs, governmental organizations, and distribution initiatives.
- Work closely with internal teams: Quality, Supply Chain, Finance, Manufacturing (GMS), Network Strategy (GNS), Quality Operations (QO), and External Supply Quality Assurance (ESQA).
- Liaise with National Regulatory Authorities and distribution partners as required.
- Pharmacovigilance
- Monitor PV activities, including mailbox checks, case entry into PV Express, and distributor training.
- Provide follow-up and feedback to internal teams.
- Distributor & Local Technical Representative Management
- Train and support distributors on pharmacovigilance, temperature management, and regulatory compliance.
- Budget & Reporting
- Manage regulatory budgets and resource allocation.
- Report regulatory activities, metrics, and KPIs to regional leadership.
- Documentation & Systems
- Prepare and approve product labels and package inserts.
- Archive regulatory documents in compliance with global standards.
- Utilize systems such as Veeva Vault, SAP, ETS-RT/ETS-ST, MAR/SCR, APS for regulatory tasks.
Qualifications & Experience
- Advanced degree in Veterinary Sciences or related field.
- Minimum 5–8 years of experience in Regulatory Affairs within the veterinary or pharmaceutical industry.
- Strong knowledge of regulatory processes, dossier compilation, and pharmacovigilance.
- Proven ability to engage with diverse stakeholders, including governmental bodies and NGOs.
- Excellent organizational, communication, and project management skills.
- Proficiency in regulatory systems and tools (e.g., Veeva Vault, SAP).
- Fluency in English; French is an advantage.
Why Join Us?
- Be part of a global organization committed to improving animal health and welfare.
- Work in a dynamic environment with opportunities for regional impact and professional growth.
#LI-DNP #LI-CES
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
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