* Regulatory Affairs - Pharmacovigilance - Quality Assurance - Pharma
* Healthcare - Lifescience - Veterinary Animal Health - Animal Nutrition - Belgium
About Our Client
Our client is a fast- moving large-scale pharmaceutical company with over 3000 employees and an international presence in more than 20 countries. They have a significant impact on the Life Sciences sector and are renowned for their commitment to innovation, development and quality. Strong growing ambitions are expected over the 5 coming years.
Job Description
The Regulatory Affairs, Quality & Pharmacovigilance Manager - Animal Health BELUX will oversee regulatory submissions, compliance, and pharmacovigilance activities for our veterinary products. This role is critical in ensuring that our products meet all regulatory requirements and maintain the highest standards of safety throughout their lifecycle.
As a successful Regulatory Affairs, Quality & Pharmacovigilance Manager - Animal Health BELUX, you will have the following responsibilities:
* Regulatory Strategy: Develop and implement regulatory strategies to support product registration and compliance with local and international regulations.
* Regulatory Submissions: Prepare and submit regulatory documents to relevant authorities (e.g., USDA, EMA, FDA) for product approvals and renewals.
* Compliance Management: Ensure ongoing compliance with regulatory standards, including product labeling, advertising, and distribution.
* Regulatory Documentation: Maintain regulatory documentation and databases, ensuring alignment with company systems and standards.
* Quality Assurance: Develop and maintain quality management systems (QMS) to ensure product quality and compliance with Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practice (GVP-Vet)
* Pharmacovigilance: Monitor and report adverse events related to veterinary products, ensuring timely and accurate reporting to regulatory bodies.
* Regulatory Intelligence: Stay informed about current and upcoming regulations affecting veterinary products and advocate for company interests.
* Lifecycle Management: Manage regulatory and quality aspects of product lifecycle, including post-market surveillance and updates.
* Training and Support: Provide regulatory and quality advice and training to internal teams, ensuring awareness and understanding of regulatory and quality requirements.
The Successful Applicant
As a successful Regulatory Affairs, Quality & Pharmacovigilance Manager - Animal Health BELUX, you will have the following profile:
* Degree in Veterinary Medicine (DVM), Pharmacology, Quality Management, or a related field.
* +5 years of experience in regulatory affairs, quality assurance, and pharmacovigilance within the animal health sector.
* Registered as EU Qualified Person for Pharmacovigilance
* Strong knowledge of global regulatory frameworks (e.g., EMA, FDA-CVM, VICH guidelines).
* Experience in managing regulatory submissions and post-marketing pharmacovigilance activities.
* Excellent communication, project management & organisational skills.
* Experience in developing and maintaining quality management systems.
* Fluent in English, French and Dutch
What's on Offer
As a successful Regulatory Affairs, Quality & Pharmacovigilance Manager - Animal Health BELUX, you will have:
* A dynamic and mission-driven work environment focused on animal health and welfare.
* Opportunities for career growth and development in a global company.
* Competitive compensation and benefits package.
* Hybrid or flexible work arrangements (as applicable).
#J-18808-Ljbffr