CMC Technical-Regulatory Affairs Lead

Responsibilities

Area of responsibility 1: [CMC technical-regulatory strategy]

Main activities:
Lead or oversee development of the technical-regulatory strategies for assigned projects and relevant geographies throughout the product lifecycle:

• Identify precise documentation required by regulation for the creation and maintenance of Marketing Authorization files; incorporate local regional specificities and regulatory needs into the overall plan.

• Prepared strategies in collaboration with relevant stakeholders - e.g., global Regulatory Affairs teams, QA (US and Corporate), and global R&D, and IO centers.

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

• Ensure strategies incorporate regulatory intelligence - i.e., up-to-date knowledge of regulations, guidelines, pharmacopeias, as well as new trends.

• Validate high-risk strategies with regulatory authorities; prepare associated technical briefing documents and/or lead meetings with regulatory authorities as necessary.

Expected results:

• An accurate and exhaustive list of required regulatory studies and assessment of risks taken is documented

• Action plans are ambitious but realistic and are compatible with regulatory constraints

• Contributes to planning in line with the selected scenario, in collaboration with relevant stakeholders

• Deadlines are guaranteed through close monitoring

• Stakeholders are alerted about deviations in timing or expected documentation

• A positive relationship with regulatory authorities is maintained, ensuring the company's good standing

Area of responsibility 2: [Writing dossiers]

Main activities:

Ensure the preparation of approvable CMC dossiers (i.e., EU MAA part 2 / CMC TS, IL/LOQ responses, variation dossiers, and statutory reports):

• Write CMC dossiers in adherence with the company’s internal writing rules; if necessary, manage the subcontracting of writing

• Manage responses to CMC questions from national authorities with efficiency and on time.

• Global transfer: at the end of the registration procedure, ensure the transfer of file information to the departments concerned

Expected results:

• Dossiers are complete and adhere to regulatory requirements

• Judiciously written arguments with calculated risk-taking, in lieu of studies wherever possible, to carefully manage cost and risk vs. benefit

• Dossiers are submitted according to the timing defined with the project team

• Responses to Agency questions/comments are submitted within the deadlines defined by the Agency or project team

Area of responsibility 3 : [VICH stability study design and management]

Main activities

• Design regulatory stability studies and organize and monitor their operational implementation internally or externally. Ensure the delivery of stability protocols and reports in accordance with Virbac practices and the guidelines in force for the geographic areas concerned.

• Participate in the selection of subcontractors. Monitor the subcontracting budget.

• In the event of an OOS, alert management and project team members, trigger actions according to the OOS management procedure, and suggest avenues for investigation

Expected results:

• Study costs are accurately reflected in the budget and validated with management, based on the products concerned and the analyses to be performed

• Subcontractors are managed through direct contact; regulatory and analytical content of protocols and reports is discussed and validated with QA and Analytical team members

• Test results and deliverables are obtained within the time limits defined in the action plans.

Area of responsibility 4 : [Supervision of activities and professional development]

Main activities

• Develop and administer the budget for US CMC Regulatory expenses

• Works with employees to identify development opportunities in accordance with business needs as well as employees individual career growth goals

• Educate and broaden technical-regulatory knowledge through training opportunities and knowledge sharing

• Effectively and accurately write and deliver employee performance-related documents on time and in accordance with company policies and timelines

Expected results:

• The Regulatory budget is managed effectively to support the group’s work and professional development.

• The Regulatory team is managed through coaching, training, support and promotion of employee development.

Profile

Competencies (reference job catalog):

• Collaborate with others → Level 4: Acts as a role model of collaboration

• Customer focus → Level 4: Establishes deep and broad relationships

• Drives innovation → Level 3: Encourages innovative ideas

• Drives performance and results → Level 3: Focuses on results and faces obstacles

• Learning agility → Level 3: Develops self and others

• Optimizes talent → Level 4: Aligns talent needs with strategy

Requirements (Diploma and experience)

Higher scientific training in the field of health; strong and broad scientific knowledge base linked to drug development (knowledge in analytics, chemistry, formulation, pharmacokinetics)

8 to 10 years diverse pharmaceutical regulatory experience, with at least 5 years in the Veterinary pharmaceutical industry

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

Experience with several pharmaceutical forms

Experience in assembling CMC-related submissions to Regulatory Authorities

Position requires a minimum of 20% travel. Willing to travel internationally (Americas, Europe, Asia)

Skills

• Very strong knowledge and understanding of pharmaceutical regulatory texts. Ability to apply this knowledge strategically and operationally to development plans

• Excellent writing skills in English (US) and fluent spoken English (US)

• Easy written and oral communication; posture and behavior adapted to the authorities

• Empower and motivate team members

• Skills in analyzing problems and situations

• Ability to think smart, write smart, adaptable to changes in situations and tactics

• Ability and willingness to propose realistic, pragmatic and original solutions in accordance with Virbac's values

• Manage execution showing drive and results orientation; able to carry out several projects simultaneously

• Demonstrates a capacity for anticipation and planning; Ability to organize multitasking effectively in an environment guided by deadlines (authority deadlines)

• Attention to detail to ensure overall consistency

• Knows how to work in a team and develop cross-functional cooperation; but also knows how to work independently and is able to make decisions in his field when there is no clear right or wrong answer.

• Knows how to influence and persuade others to get their ideas across

• Ability to work with people from diverse cultures and encourages intra-R&D collaboration

• Understands GMP principles

• Mastery of computers and information technologies (writing, videoconferencing, web research, making presentations, etc.)