Director CMC regulatory at Ipsen providing strategic oversight of regulatory processes and systems. Collaborating with stakeholders to enhance regulatory efficiency and effectiveness.
Responsibilities
Provide strategic and technical CMC regulatory input to improve processes and facilitate interfaces with stakeholders
Responsible for mapping CMC regulatory activities at the different locations
Ensure processes, systems and corresponding metrics are in place
Lead and drive the development and implementation of a sustainable improvement system
Contribute to the establishment of a culture of continuous improvement mindset
Establish process to initiate, plan, execute, monitor, and report on the overall CMC regulatory Portfolio activities
Create visibility and reporting on CMC regulatory portfolio
Ensure a CMC regulatory platform is built and maintained
Ensure effective and collaborative working relationships within the Global CMC-Reg teams and all other associated functions/stakeholders
Support line manager on budget/ resource planning and monitoring for CMC projects.
Requirements
Advanced degree in scientific discipline, major in pharmaceutical/Biological/Chemical Science or relevant scientific discipline
Minimum 10 years’ experience in CMC regulatory affairs field in a management role
Significant depth of change management experience
Proven ability to communicate (written/oral) with various functions.
Fluency in English
Ability of cross functional co-operation.
Strong ownership and cross boundary working mindset.
A strong capability in problem solving.
Strong ability of lobby, influence, and negotiation
Strong ability to map and define end to end processes.
Continuous improvement mindset
Ability to coordinate, influence and lead people or a virtual team.
Benefits
EHS responsibilities
Respect and enforce applicable EHS regulations and procedures.
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