RA Life-cycle Management Manager
A job vacancy for a RA Life-cycle Management Manager has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
- Leading assigned production transfer projects and other initiatives related to life cycle activities triggered by Client Technical Operations.
- Acting as a single point of contact for cross-functional project teams, independently providing strategic direction on production transfer projects for RA GDD, driving and monitoring progress and deliverables.
- Interacting with experts from RA GDD development units, RA GDD CMC, RegCMC BTDM, Operations, Finance, Regional representatives (MoW, LaCan, EU), Policy and Quality Assurance to align a common RA GDD approach to handling production transfer projects and other initiatives from planning, execution to communication and completion.
- Single point of contact for assigned cross functional projects as relates to RA GDD providing input on regulatory requirements, timelines, and risks.
Leading the assessment of RA GDD resources (DU, Operations, Regional representatives and COs) required for the assigned projects.
- Together with RA GDD Finance, formalising resources required and negotiate Service Level Agreements with NTO for the assigned projects.
- Coordinating with regulatory associates and with the RA GDD CMC project manager for assigned cross functional projects to deliver aligned regulatory strategy, agreed upon project timelines and consistent regulatory requirements.
- Tracking progress of assigned projects, including timelines, dossier deliveries and resource utilisation. Alert project team and RA GDD management to risks, issues and achievements.
Facilitating communication between regulatory associates and cross functional project team members.
- Supporting regulatory associates sourcing information and providing team contacts.
- Ensuring amongst the stakeholders within and external to RA GDD a common understanding and agreement of roles and responsibilities.
- Leading or participate in multidisciplinary teams focusing on identifying gaps, escalating concerns and supporting and driving continuous improvement and management initiatives.
- Supporting Lessons Learned sessions and trainings within and external to RA GDD leading to improve strategies and decisions on common regulatory approaches.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.