Description:
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.
Skills
- Project Management: Ability to implement tactical goals for customer or internal projects, prioritize parallel tasks, identify potential roadblocks, and initiate appropriate countermeasures.
- Analytical Thinking: Structured, analytical, systematic, and independent working style with discretion to act within operating policies and determine priorities.
- Problem-Solving Skills: Capability to analyze and solve problems, offering pragmatic solutions tailored to tasks or projects. Strong service orientation.
- Leadership & Training: Ability to train and support junior or new colleagues in daily activities and lead small projects with clearly defined scope.
- Relationship Management: Skilled in managing internal and external (client) relationships at both operational and team lead levels.
- Communication & Presentation: Excellent written and verbal communication skills, including the ability to present confidently and propose solutions to decision-makers.
- Language Proficiency: Business fluency in English and proficiency in the local language (as appropriate).