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.
Virbac Animal Health is seeking a Senior CMC Regulatory Scientist for our Regulatory Affairs Team. The CMC Regulatory Scientist is responsible for ensuring compliance with relevant regulatory reporting requirements and preparing quality and timely CMC submissions to the US FDA Center of Veterinary Medicine (CVM).
Qualified candidates must possess a Bachelor’s degree in a scientific field (chemistry, biology, animal science, or related field) or equivalent experience.
2 to 4 years regulatory experience, with at least 1 year in the veterinary pharmaceutical industry. Preference for candidates with FDA/CVM submission experience
Previous interaction with the FDA (e.g., meeting attendance, informal communication), preference for experience interacting with CVM
Position requires a minimum of 5% 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 Regulatory Compliance]
Main activities
Prepares and submits postapproval CMC submissions and other regulatory correspondence in accordance with agreed timeframes and in compliance with US regulations.
Participates in CMC team meetings, and actively seeks guidance from CMC team members when needed to ensure high quality submissions to CVM.
Participates in negotiations with CVM during the regulatory submission approval process.
Ensures statutory reporting activities are accomplished efficiently and effectively.
Maintains up to date records and archives submissions to CVM per the department’s processes
Expected results: Complete, accurate, and timely review and submission of assigned regulatory documents
Area of responsibility 2: [Regulatory advice and strategy inputs]
Main activities
Participates in inter-company organizations focusing on specific industry-related issues.
Monitors regulatory agency and industry changes, trends and requirements in order to contribute effectively to postapproval regulatory strategies.
Shares regulatory intelligence internally with other CMC colleagues, and other departments where relevant.
Participates in technical support, advice and strategy to other teams within Virbac (e.g. R&D, marketing, quality, formulation, clinical).
Expected results: Virbac’s ability to manufacture and sell products is maintained as a result of effective regulatory strategies.
Area of responsibility 3: [Cross-Functional Collaboration]
Main activities
Participates in inter-departmental meetings discussing product issues and priorities to develop clear and realistic plans with milestones to achieve the desired outcomes.
Collaborates with other departments to identify and understand areas for improvement and potential cost savings.
Manages process for timely receipt of documentation necessary for inclusion in postapproval submissions to CVM.
Provides regulatory support during regulatory authority site inspections.
Expected results: Timely reporting of product changes and maintenance of product registrations
Area of responsibility 4: [Relationships with regulatory agencies]
Main activities
Participates in working and industry groups to provide input to shape the regulatory landscape.
Develops and maintains a positive working rapport with governing regulatory agencies.
Expected results: A positive relationship with regulatory authorities, ensuring the company's good standing
Profile
Requirements (Diploma and experience)
Bachelor’s degree in a scientific field (chemistry, biology, animal science, or related field) or equivalent experience
2 to 4 years regulatory experience, with at least 1 year in the veterinary pharmaceutical industry. Preference for candidates with FDA/CVM submission experience
Previous interaction with the FDA (e.g., meeting attendance, informal communication), preference for experience interacting with CVM
Position requires a minimum of 5% travel.
Skills
Strong technical writing skills
Able to produce positive results with a strong sense of urgency according to required timelines
Attention to detail, and strong organizational skills
Promotes collaboration across functional boundaries
Able to grasp new concepts quickly and to assimilate and evaluate scientific data
Knowledge of and ability to interpret, understand and communicate regulations and regulatory language
Ability to read, understand and retain extensive working knowledge of procedures and company documents
Ability to maintain open communication with stakeholders and build sustainable relationships
Advanced computer skills with proficiency in Microsoft Office Suite and/or Google Workspace, and Adobe Acrobat; experience with CVM eSubmitter is a plus
Ability to comply with changing regulatory procedures and prioritize work effectively
Ability to negotiate internally and externally with regulatory agencies
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