CDI - CMC Quality and Regulatory Dossier Specialist F/H

Vetoquinol has been an independent veterinary pharmaceutical Group for over 90 years. Our fast-growing Group bases its development on the competence and involvement of its teams and on the search for innovative solutions in animal health (new projects are underway, modernization of our equipment and workspaces, a new customer approach, an opening towards biotechnologies…). More than 2500 employees distributed across 24 countries contribute daily to the satisfaction of our main client: the veterinarian. We place People at the heart of our concerns and our corporate strategy and do everything we can daily to support our Managers, develop agile skills and behaviors, and improve the well-being at work of all our employees. Strong values reflect our transformation today: Trust, Dare, and Collaborate! At Vetoquinol, we want to accomplish more, together! We invite you now to discover our institutional video: https://vimeo.com/798738206

Job Summary: Participate in defining the strategy and guidelines for drafting pharmaceutical CMC dossiers. Define and execute the drafting and follow-up steps for pharmaceutical regulatory CMC dossiers and non-pharmaceutical Quality dossiers for new products. Transfer information and knowledge to the industrial department necessary for the optimized maintenance of dossiers during the product life cycle. Contribute to monitoring and innovation in the pharmaceutical regulatory field. Contribute to the functioning of CMC projects as a team member representing the pharmaceutical development department. Main Activities: Project regulatory CMC risk management Proposes a project analysis in connection with international CMC regulatory requirements and practices and internal practices Communicates their analysis of risks and opportunities to the development teams, supporting their recommendations based on regulatory frameworks and information from technical-regulatory monitoring (publications, case studies) with the objective of balancing costs/deadlines, minimizing regulatory risks, and taking industrial constraints into account in the management of dossier life cycles Ensures that CMC dossier drafting teams are aligned on all points, requesting the RDP Scientific Committee if necessary Ensures the preparation of preparatory documents for CMC meetings with Regulatory Authorities Participates in the continuous improvement of the department's practices and frameworks by sharing their analysis of monitoring elements and previous experiences regarding Authority issues (trend detection) Drafting of Technical-Regulatory Dossiers – International In compliance with costs, deadlines, and current procedures: Formalizes the guiding principles of dossier drafting in connection with the defined regulatory CMC strategy (Quality-by-Design logic of the dossier and optimized control strategy) Defines the drafting back-planning in terms of documentation and availability dates, and alerts in case of any deviation introducing a risk to the submission date to the Authorities Collects scientific documentation and ensures the drafting of the Quality part of MA dossiers or quality dossiers for new non-pharmaceutical products (nutraceuticals, cosmetics...) in compliance with the defined guidelines Ensures the quality of pharmaceutical dossiers by ensuring compliance, CMC regulatory requirements, the writing quality of arguments, as well as the overall consistency between the different sections of the dossier Ensures the preparation of "Quality Overall Summaries" and their review and approval by the person assigned to the project (internal or external) Ensures the follow-up of responses to questions from European, US, Canada instances (and other strategic territories integrated into the project phase) Regulatory Monitoring – International (pharmaceutical products) Continuously monitors the compliance of project development plans with the evolution of international regulations (monitoring international standards and local specificities of strategic countries), analyzes and communicates the impacts on current practices and ongoing developments, alerts development teams in case of an identified project risk Participates in the general regulatory monitoring of the RDP in connection with the domains and territories covering the department's priority axes Document management and preservation of company knowledge Organizes and transfers the final version of Quality dossiers and the elements necessary for the compliance of production operations at the product launch stage to the Production department Ensures that documentation as well as associated knowledge are communicated to the industrial department in order to maintain, in an optimized manner, the dossiers during the product life cycle (transfer of a scientific-regulatory dossier backed by the regulatory dossiers submitted by the RDP) Main working relationships (outside of the hierarchical link): Scientific Direction, Project Managers, Regulatory Affairs, Industrial Direction Active Pharmaceutical Ingredient manufacturers and "Contract Development" and "Manufacturing Organizations"

You have a scientific Master's degree or have followed an Industrial Pharmacist curriculum with a specialization in pharmaceutical regulation and law, regulatory affairs in health industries, or drug sciences. You possess a good level of English (equivalent to B2/C1) allowing you to communicate orally and in writing and master IT tools such as Microsoft Office. Knowledge of international pharmaceutical regulation (EMA, FDA, VICH) Knowledge of pharmaceutical development (chemistry and manufacturing processes) First experience of 3 to 5 years in a technical-regulatory function You have good interpersonal skills and a strong team spirit. You possess good analytical and synthesis skills, and good communication skills. You know how to demonstrate rigor and organization.

CDI position, Executive status, based in Magny-Vernois (70). Conditions & benefits: Remuneration package including a fixed salary according to your profile, variable part based on objectives, increased holiday bonus according to seniority conditions, profit sharing and incentive schemes + company savings plan, Mutual/protection insurance, Restaurant vouchers (one per day), 13 days of RTT, CSE, Support in searching for housing, Events/actions promoting well-being at work If you wish to obtain more information about Vetoquinol, we invite you to follow our LinkedIn page: https://www.linkedin.com/company/vetoquinol/ Do you not know Franche-Comté yet? We invite you to watch this video which will allow you to discover our region…. http://www.pays-de-lure.fr/pays_de_lure/communaute_de_commune.htm Do you wish to develop yourself within a human company with strong values? Join us!