Senior Regulatory CMC Specialist
Virbac Corporation
Job Description
Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
• Managing the submissions procedure and interactions with Authorities according to local requirements,
• Complying with the procedure timeline,
• Organize feedback to Authorities within the deadlines,
• Give visbility to internal stakeholders on the main milestones, the expected date of approval, providing regulatory strategic input for new development programs,
• Geo-extension of existing products and regulatory life cycle of marketing authorization,
• Establishing recommendations on regulatory feasibility,
• Go/no-go decision process,
• Establishing and agreeing on regulatory action plan to manage new submissions and regulatory life cycle,
• Organizing agency consultations,
• Ensuring regulatory watch and provide recommendations (opportunities and risk) for the management of the product & projects portfolios,
• Obtaining new marketing authorisations,
• Maintaining existing marketing authorisations in compliance with the relevant regulations in the different countries/ regions.
A Senior Specialist applies advanced knowledge of job area typically obtained through advanced education and work experience.
Responsibilities may include:
• Managing projects / processes, working independently with limited supervision.
• Coaching and reviewing the work of lower level professionals.
• Problems faced are difficult and sometimes complex.
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