Global CMC Tech-Reg Manager

2 weeks ago

Bridgeton, United States Virbac Full time
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.

Global CMC Tech-Reg Manager

Virbac Animal Health is seeking a Global CMC Tech-Reg Manager to join our Research and Development team. As part of the group's Product Innovation strategy, the Global CMC Tech-Reg Manager leads the various global regulatory assessments (US, EU, RoW) and prepares the CMC part of the Marketing Authorization dossier in order to ensure its admissibility by the authorities in accordance with the objectives of growing the product portfolio.

The manager participates in the evaluation of the studies to be performed to meet regulatory requirements, speaks to technical topics during meetings with the authorities or internally, in order to coordinate the content of the CMC part of the dossier; responds to questions from the authorities, respecting costs and deadlines.

Qualified candidates must have higher scientific training in the field of health; strong scientific base linked to drug development(knowledge in analytics, chemistry, formulation, pharmacokinetics); Minimum 4 years of experience in the regulatory field (CMC file) or other relevant experience for pharmaceutical coordination.

Several registration experiences of the CMC technical section with the FDA. Experiments on several pharmaceutical forms.

Candidates must also possess strong written and oral communication skills along with a willingness to travel internationally.

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

Overview (reference job catalog)

Job description (ENS.07.021.P30 Tech-Reg Product - Senior Specialist):
  • Defining product technical characteristics according to the regulatory environment and product target profile
  • Ensuring the regulatory compliance of raw materials, seed lot system, active components, excipients, intermediates and vaccines/drug products entering into regulatory studies
  • Providing regulatory input, establishing recommendations on the acceptability of the technical options, consolidating the technical and tech-reg tactics for global products including the product development rationale, preclinical and clinical studies design for new product development, geo-extensions, and life-cycle management of marketed products
  • Writing the technical documentation according to the local requirements including registration dossiers, answers to questions and variations, tech-reg internal guidelines or position papers
  • Ensuring the regulatory watch and sharing within the company the Regulations evolution in order to maintain the expertise within the company and provide positions on draft regulations and guidance; assessing the new technologies (bridge between new technologies and regulations)
Additional job description:

Applies advanced knowledge of the job area, typically obtained through advanced education and work experience.

Responsibilities may include:
  • Manage projects /process, working independently with limited supervision
  • Coaching and reviewing the work of lower level professionals
  • Problems encountered are difficult and sometimes complex
Management Level: Professional

Job Level: Senior Specialist

Job Family: Science

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

Phase 1: Assessment phase:

Ensure development of the technical-regulatory development plan and definition of the strategy, within the framework of internal or external development (CDMO/CMO):
  • Prepares, throughout the different phases of development, the roadmaps of the global CMC regulatory strategy (US, EU, RoW) for the assigned projects (creates the development plan (DOP) document) in collaboration with the global development team.
  • Provides evaluations, opinions, and advice on the overall development plan or on specific points.
  • Participates in necessary gap analysis activities, planning and prioritizing associated regulatory strategies to close gaps. Proposes technical-regulatory scenarios with associated risk/criticality analysis based on development plans. Develops a written technical-regulatory assessment, particularly for due diligence/licensing in.
  • With a view to registration batches, precisely identifies the documentation required by regulation for the creation of Marketing Authorization files in collaboration with Regulatory Affairs (EU, US, RoW), QA (US and Corporate); ensures that local regional specificities and regulatory needs are incorporated into the overall plan
  • Proposes technical-regulatory justification to support specific data, with an associated risk/criticality assessment
  • Collaborates cross-functionally with local and global R&D centers and EU, US, RoW Regulatory Affairs
Phase 2: Operational phase - follow up and coordination:

Ensure and guarantee an approvable CMC dossier (e.g., Part 2 of the European dossier, CTD Module 3 for the US):
  • Collaborates closely with the pharmaceutical development team and the industrial operations team to generate the CMC regulatory dossier aligned with the roadmap defined to optimize marketing
  • Directs and implements CMC writing activities taking into account the global CMC strategy
  • Responsible for the CMC file generation process across all functions: ensuring that the role of each function involved in file generation (data providers) is clear and will provide the right data with the correct level of detail in accordance with regulatory requirements
  • During development of the dossier, identifies required documentation, analyzes scientific quality of content and/or deadline issues for an overall submission; negotiates delivery of source documents
  • Identifies the particular points which require consultation of the regulatory authorities. In collaboration with Regulatory Affairs, is proactive in planning and preparing materials for meetings with the authorities.
  • Acts to ensure the availability of studies necessary for submitting the file, or for answers to questions, ensuring cross-functional collaboration with all R&D experts (e.g., pK, tox, formulation, analytics, API, packaging, QA).
  • Organizes meetings to develop the DOP with the applicable departments (in EU, US, RoW); actively collaborates with other members of the development team.
Expected results:

Evaluation phase:
  • An accurate and exhaustive list of required regulatory studies is documented in development plans
  • Relevant regulatory strategies with reliable costing of studies and assessment of risks taken
  • DOP
Operational phase:
  • Guarantees ambitious but realistic action plans that are compatible with regulatory constraints
  • Contributes to planning in line with the selected scenario, in collaboration with relevant members of the development team
  • Guarantees deadlines through close monitoring
  • Guarantees consistency and coordination so that studies and documents are within the deadlines of the action plan
  • DOP update
  • Alerts manager about deviations in timing or expected documentation
Area of responsibility 2: [Writing dossier]

Main activities : writing part 2 / module 3 of the dossier and LOQ, variation dossier, writing and

expertise consistent with the overall CMC file:
  • Follows the company's internal writing rules
  • Ensures good collaboration with the teams to provide (coordination, writing and revision), within the appropriate time frame, the documents in the right format "ready to be used or submitted"
  • Collaborates with Regulatory Affairs on the preparation of support documents intended for meetings with regulatory authorities
  • Manages efficiently, in a timely manner the response to CMC questions from national authorities around the world with the support of development teams if necessary to achieve approval of the submission.
  • Writes all or part of the file and answers to Agency questions, in collaboration with the pharmaceutical coordination teams, CMC, RG, and UPC
  • If necessary, manages the subcontracting of writing or expertise
  • Provides technical-regulatory justification to support specific data
  • Global transfer: at the end of the registration procedure, organizes the transfer of file information to the departments concerned
Expected results:
  • File constructed according to sufficient regulatory requirements, according to the strategy defined and validated by its hierarchy
  • Judiciously written arguments with calculated risk-taking, in lieu of studies wherever possible, to carefully manage cost and risk vs. benefit
  • Submission of files according to the timings defined with the project team and validated by its hierarchy
  • Responses to Agency questions/comments are submitted within the deadlines defined by the Agency or project team
Area of responsibility 3 : [Pharmaceutical files: subcontracting of certain (analytical) studies]

Main activities
  • As part of regulatory stability and geo-extension studies, organizes the technical implementation of studies internally or externally (CRO), including updates or additional validation of existing methods, regulatory stability (e.g. 30°C 75 RH) complementary with the various Virbac R&D centers. Ensures the delivery of protocols and analytical reports in accordance with Virbac practices and the guidelines in force for the geographic areas concerned.
  • VICH stability collaboration upon submission: leader but in collaboration with analytics
  • Establishes and monitors of the subcontracting budget
  • Participates in the selection of subcontractors
  • Ensures the monitoring the activities and technical progress of studies (VB Studies, budget, OOS, internal communication),
  • In the event of an OOS, alerts management and project team members, triggers actions according to the OOS management procedure, and suggests avenues for investigation
  • Analytical transfer: organizes the transfer of analytical methods if necessary to successfully carry out the studies
Expected results:
  • A budget is established and validated with management and the project team, based on the products concerned and the studies to be carried out
  • Subcontractors are managed through direct contact; regulatory and analytical content of protocols and reports is discussed and validated with analytics
  • Obtaining results and deliverables within the time limits defined in the action plans (e.g.: stability point deadlines).
  • In the event of unexpected results, solutions and/or other alternatives are promptly proposed in collaboration with the other VB services involved (QA, the analytical department), and the subcontractor.
Area of responsibility 4 : [Regulatory intelligence]

Main activities

Active participation in monitoring directly linked to projects; contributes to the CMC technical-regulatory monitoring group by providing topics:
  • Conducts scientific monitoring and assesses the impacts of regulatory developments on ongoing studies, suggesting adaptations if necessary
  • Alerts project team members and participates in the development of action plans
  • Collaborates on different topics with internal (R&D, industrial) or external partners (subcontractor, experts)
  • Participates in the development of comments on regulatory texts
  • Maintains up-to-date knowledge of guidelines, pharmacopeias for all regions of the world, as well as new trends.
Expected results:

Deliverables: regulatory intelligence report, text comments, presentations, impact assessment on its projects (studies, duration, costs)

Profile

Competencies (reference job catalog):
  • Collaborate with othersLevel 3: Removes obstacles to collaboration
  • Customer focusLevel 3: Acts as a trusted advisor
  • Drives innovationLevel 3: Encourages innovative ideas
  • Drives performance and resultsLevel 3: Focuses on results and faces obstacles
  • Learning agilityLevel 2: Incorporates feedback
  • Optimizes talentLevel 2: Builds and develops a talent network
Requirements (Diploma and experience)

Higher scientific training in the field of health; strong scientific base linked to drug development (knowledge in analytics, chemistry, formulation, pharmacokinetics); Minimum 4 years of experience in the regulatory field (CMC file) or other relevant experience for pharmaceutical coordination.

Several registration experiences of the CMC technical section with the FDA. Experiments on several pharmaceutical forms.

Skills
  • Very strong knowledge and understanding of regulatory texts (guidelines, Pharmacopoeias) applicable in the USA, Europe and Asia. 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
  • 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
  • Demonstrates a capacity for anticipation and planning; Ability to organize multitasking effectively in an environment guided by deadlines (authority deadlines)
  • Very strong results and timing orientation; organized, and able to carry out several projects simultaneously
  • 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
  • Willing to travel internationally (Americas, Europe, Asia)
  • Mastery of computers and information technologies (writing, videoconferencing, web research, making presentations, etc.)


Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension.

Joining Virbac means joining dynamic teams ambitious for success.

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