Ipsen

Director CMC Regulatory Processes and Systems

Ipsen

full-time

Posted on:

Location Type: Hybrid

Location: Boulogne-Billancourt • 🇫🇷 France

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Job Level

Lead

About the role

  • 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
CMC regulatory inputchange managementprocess mappingportfolio managementcontinuous improvementproblem solvingnegotiationinfluencecross boundary working
Soft skills
communicationcollaborationownershipleadershipcross functional cooperation