The Role: To ensure the correct development of Intas B2B external projects with the aim of controlling project scope, timelines, and costs, and towards obtaining a successful drug product, a cost-effective manufacturing process, and a successfully compiled regulatory dossier.The Successful Candidate Will:Coordinate and lead the development of Intas B2B assigned projects with external CDMOs, CROs, and other key players such as API suppliers, and scientific and regulatory consultancy companies.Interact and align with in-house key departments such as R&D, BD, IP, regulatory, and operations.Develop target product profile, project plan, and project costs.Manage project scope, timelines, milestones, risks, and costs. Use project management system tools for management and Gantt preparation.Report status of assigned projects to Intas B2B VP Innovation & Portfolio, and to other key internal and external stakeholders.Ensure realistic baselines (scope, time, and cost).Manage and supervise the CDMO during all the different stages of formulation and analytical method development (compatibility study, reference product characterization, API characterization and solubility study, FDF formulation, analytical method for API and FDF analysis). Assist R&D team in definition of CQA for FDF.Assist Project Leader in CDMO selection and in tech transfer processes to external CMOs or to own manufacturing sites located in the UK or India.Assist Portfolio team in feasibility analysis and validation of potential new AVM or generic projects.Assist Project Leader and regulatory team in scale-up management and coordination with CMOs up to completion of the regulatory dossier.Assist Portfolio and regulatory teams in managing and supervising the external CRO during the clinical development activities. Coordinate clinical trial material preparation between the CDMO and CRO.Support regulatory team with technical justification and documents requested by health authorities during dossier evaluation.Minimum Requirements:Proven experience within project management in a pharmaceutical environment or in clinical development.Able to demonstrate that he/she can deliver results.Proactive and tenacious with the ability to follow up.Proven ability to deal with complexity.Excellent communication and interpersonal skills, able to liaise with stakeholders at all levels and navigate cultural differences with ease.Strong organization and administration skills with the ability to make good decisions, have a strong eye for detail, and prioritize a busy workload to meet deadlines.Good team player, but equally happy working autonomously.A degree-level qualification in Chemistry/Pharmacy (preferably with a master's in project management).#J-18808-Ljbffr