Sr Manager, Global Regulatory CMC Process Owner and Training Lead

Job Description

The Global Regulatory CMC Business Process Management Lead is accountable for Global RegCMC business processes, quality management, and training syllabus.

·Oversee E2E processes and their improvements that support Global RegCMC Operating Model

·Responsible for managing and overseeing the objectives and performance of aprocessthrough Key Performance Indicators (KPI)

·Drive the creation and maintenance of the Global RegCMC Quality Manual in line with Global RegCMC strategy

·Contribute to planning, process and continuous improvement within Global RegCMC

·Together with CI Lead, lead improvement initiatives identified by Global RegCMC leadership teamin order to improve processes and effectiveness

·Coordinate creation and maintenance of supporting Policies, Standard Operating Procedures and standards

·Ensure maintenance of Job Descriptions, CVs and training plans across Global RegCMC organization

·Governance of operational support model, including operational procedures and user administration

Qualifications

In this role, you will be part of Global RegCMC Strategic Operations and Business Excellence team and will report to Head of this team. This candidate must have proven internal and external leadership and ability to work cross-functionally and globally. Strong communication and interpersonal skills are required.

·Minimum Bachelor’s degree (Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science preferred) and 7 years of experience (pharmaceutical/biotechnology industry highly preferred), with 4 years Global CMC regulatory experience and / or Regulatory Operations.

·Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.

·Demonstrate excellent leadership and verbal and written remote working communication skills.

·Demonstrated competency in planning and tracking projects of high complexity and risk with clearly defined critical paths; delivering projects on time and on budget.

·Proven ability to create strong working relationships in a global setting.

·Enthusiastic orientation to teamwork: works collaboratively, effectively and efficiently with others internally and externally.

·Project Management skills.

Advanced degree in scientific discipline (Masters or PhD) is highly preferred

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.