Environmental Compliance Manager at Micron overseeing environmental compliance and regulatory strategy for New York project. Collaborating with experienced professionals to build effective solutions.
About the role
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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