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 batches, precisely identifies the documentation required for the creation of the CMC technical section, or post-approval changes

• For assigned R&D projects, designs VICH regulatory stability studies and organizes and monitors their operational implementation internally or externally.

• Ensures the delivery of stability protocols and reports in accordance with Virbac practices and the guidelines in force for the geographic areas concerned

• Ensures all relevant studies are designed with an international view, to maximize the use of data internationally, thereby reducing costs and overall timelines

Expected results: Virbac’s abilities to obtain marketing authorizations, and manufacture and sell products are ensured as a result of effective regulatory strategies and readily accessible documentation.  

Area of responsibility 3: [Cross-Functional Collaboration and External Relationships]

Main activities 

• Participates in inter-departmental meetings to discuss project issues and priorities and develop clear and realistic plans with milestones to achieve the required goals.

• Builds long term effective relationships and open communication within Virbac US, with Virbac France, and other relevant collaborators (e.g. contract organizations, other Virbac subsidiaries) in order to provide accurate information and timeframes.

• Collaborates closely with the pharmaceutical development team and/or the industrial operations teams to generate CMC regulatory dossiers (pre- and post-approval) aligned with the defined roadmap and to optimize marketing

• Collaborates with other departments to identify and understand areas for improvement and potential cost savings.

• Participates in industry working groups to help shape the regulatory landscape.

• Develops and maintains a positive working rapport with the governing regulatory agencies, and contract organizations.

• Provides regulatory support during regulatory authority site inspections.

Expected results: A positive relationship with regulatory authorities, and internal and external collaborators, ensuring the company's good standing and continued relationships.

Area of responsibility 4:  Mentoring and Driving CMC Team Improvements

Main activities

• Mentors junior regulatory staff, providing a supportive, coaching oriented, inclusive environment for new colleagues to learn quickly and enable them to excel in their role  

• Supports new and existing colleagues on the CMC team to share learnings

• Suggests and helps drive improvements to team processes and other CMC-regulatory related processes within Virbac

Expected results: New team members are supported and integrated, and can assume new role(s) quickly; existing team members can continue to grow and learn pre-and post-approval regulatory strategy design 

Profile

Requirements (Diploma and experience)

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.

Skills

• Strong working knowledge of current pharmaceutical regulations

• Detail and deadline-oriented

• Effective negotiation skills

• Sound technical knowledge and excellent writing skills

• Ability to work independently and in a team environment 

• Driving results through a combination of  strong organizational,priority setting, and collaboration skills

• Proficient with computer programs e.g. Microsoft Office, Adobe Acrobat

• Ability to analyze problems and situations effectively and anticipate potential impacts beyond the scope of one’s own function/role

• Communicate effectively and influence others while building and maintaining positive collaborative relationships across functional & geographical boundaries (“one team” approach)

• Communicate with dialog and interactions that foster a respectful and positive work environment