Description:
Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.
The Regulatory Affairs Specialist is responsible for the execution of tasks and all aspects of technical delivery in the field of Regulatory Affairs.
Responsibilities
- Client Relationship Management: Develop and maintain strong client relationships, identifying opportunities to enhance service support and reporting to the Line Manager.
- Regulatory Processes: Participate in regulatory activities to obtain and maintain marketing authorizations for veterinary medicinal products, including applications, renewals, and variations.
- Documentation Management: Prepare, review, and compile documents for regulatory affairs projects with attention to detail and compliance.
- Client and Health Authority Communication: Serve as a liaison between clients and Health Authorities, ensuring clear and professional communication.
- Scientific Advice & Representation: Provide support during scientific advice procedures and represent clients in discussions with Health Authorities.
- Project Planning & Execution: Plan and execute client projects in alignment with KPIs, coordinating project teams consisting of internal colleagues and external qualified partners.
- Regulatory Strategy Consultancy: Offer guidance to colleagues and clients on Regulatory Strategy and Procedure Management.
- Regulatory Intelligence: Continuously develop and maintain regulatory knowledge, apply insights to client projects, and actively share expertise with colleagues.
- Seminars & Expertise Sharing: Present seminars and lectures for colleagues, clients, and professional audiences. Contribute expertise to the department and distribute knowledge effectively.
- VDC Strategy Support: Assist with the implementation and optimization of VDC strategies.
- Process Optimization: Comply with internal processes, contribute to their optimization, and maintain high standards.
- Commercial & Business Development Support: Support VDC-led commercial, marketing, and business development activities, including proposal input and strategic planning.
- Financial Reporting: Provide accurate and timely reporting to ensure delivery within budget, address invoicing queries, and offer project insights.
- On-Site Regulatory Support: In agreement with the Head of VDC REG, provide regulatory support to GCS clients on-site.
Experience
- Veterinary Product Expertise: Proven experience in supporting veterinary medicinal products, ideally with veterinary qualifications.