Lead/Senior CMC Regulatory Scientist

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.  

Lead/Senior CMC Regulatory Scientist

Virbac Animal Health is seeking a Lead/Senior CMC Regulatory Scientist for our Regulatory Affairs Team. The Lead/Senior CMC Regulatory Scientist participates in the design and/or evaluation of the studies to be performed to meet regulatory requirements, and defines the regulatory strategy for US submissions.  The Lead/Sr. CMC Regulatory Scientist prepares CMC submissions in order to ensure admissibility by the authorities in accordance with the objectives of: growing the product portfolio, ensuring life cycle management

Qualified candidates must possess the following:

Bachelor’s degree or higher in a scientific field (chemistry, biology, animal science, or related field), or equivalent experience

6 to 8 years (Lead); 9+ years (Senior) diverse pharmaceutical regulatory experience, with at least 3 years in the Veterinary pharmaceutical industry.    

Previous extensive direct interaction with the FDA, preference for experience interacting with CVM

Experience in CMC aspects of Regulatory Affairs in GMP manufacturing

Experience in assembling CMC-related submissions to Regulatory Authorities

Position requires a minimum of 15% travel.

This exciting position will work in Bridgeton, MO.  It comes with an excellent benefits package including generous time off including 13 Holidays, Floating Holidays, Vacation, Sick time.  401k + match, life, medical, dental, and vision benefits, and more!

Responsibilities 

Area of responsibility 1: [CMC Technical-Regulatory Strategy: R&D Projects and US Life-cycle management ]

Main activities

• Leads or oversees development of US CMC technical-regulatory strategies for assigned projects as part of US or international R&D teams, or directly with contract organizations

• Prepares technical-regulatory gap analyses. Proposes technical-regulatory scenarios with associated risk/criticality analysis based on business needs. 

• Provides feedback on proposed manufacturing changes to commercialized products

• Writes, or oversees writing and conducts reviews of post-approval submissions, US CMC technical sections, or other CMC submissions as appropriate for the project (e.g. H submissions, protocols, meeting briefs)

• Validates high-risk strategies with regulatory authorities; prepares for and leads meetings with regulatory authorities as necessary.

• Ensures all submissions to CVM are submitted by the agreed upon deadline (whether CVM and/or internal timelines), or if needed, that timelines are re-negotiated in advance of deadlines

• Acts as a subject matter expert for pre- and post-approval changes within Virbac for assigned projects/products

Expected results: Complete, accurate, and timely review, submission, archiving, and approval of assigned regulatory documents.

Area of responsibility 2: [Regulatory studies and documentation]

Main activities 

• Maintains up to date records, and shares and archives submissions to CVM per the department’s processes and within agreed upon timeframes

• Provides input into technical documentation including specifications, protocols, and reports for various CMC topics to support US CMC submissions as needed and ensure the studies conducted will ultimately be acceptable to CVM

• With a view to registration