Global Regulatory and Standards Manager for Pharmaceutical Packaging and Controlled Environments (H/F)
DUPONT
Luxembourg, District de Luxembourg
il y a 1j
source : A3P Opportunities

DuPont Safety & Construction is a $5B global business that provides a range of products and solutions to protect people, property and processes and is the home of well-known brands, such as Tyvek®, Kevlar® Nomex®, Styrofoam®, and Corian®.

As part of our growth planning in Tyvek®, we seek a global regulatory and Standard Manager who can develop and implement a global regulations and standards strategy in Pharmaceutical Packaging and Controlled Environments.

Scope : Responsible for establishing and executing a global regulatory and standards strategy designed to effectively and expertly support global business objectives for Pharmaceutical Packaging and Controlled Environments. Job Description :

  • Develop and implement a global regulations and standards strategy in Pharmaceutical Packaging and Controlled Environments in support of business objectives
  • Develop a regulatory map & knowledge base to identify key regulatory issues, stakeholders, activities and events in Pharmaceutical industries
  • Establish a timeline with key milestones and measurements of success for regulatory advocacy work streams and ensure the progress is on track
  • Monitor the development of regulatory and standard initiatives and communicate potential business impact to business management
  • Effectively manage and build relationship with targeted regulators, industry experts, professional Influencers, thought leaders in the industry and other stakeholders
  • Participate, contribute and provide leadership in targeted standard development organizations and industry associations
  • Develop papers on key regulatory, standards and industry issues and present in customer events and external conferences
  • Support the demand creation through advocacy and education with key industry stakeholders
  • Provide guidance and training to internal organizations on regulatory topics, strategy and key activities in support of local regulatory engagements in Pharmaceutical industries#LI-JS1 Job Qualifications :
  • Bachelor or above degree in relevant scientific and / or engineering discipline
  • Experience with aseptic processing sterility assurance, quality assurance, quality risk management, FDA and EMA regulations, with aspects related to design qualifications and process validations, environmental monitoring, microbiology, quality controls as well as GMP compliance, audits and inspections
  • Knowledge of sterilization and controlled environment standards is a plus
  • Experience in clean room garments and gowning qualifications is a plus
  • Experience in the development of standards and guidelines for industry is a plus
  • Strategic thinking, innovative, and entrepreneurial initiative
  • Proven ability to network, collaborate, advocate, and demonstrate leadership both within and outside of DuPont, including across functions, networks, customers, regulators and other stake holders
  • Self-driven and accountable
  • Actively listening, inspiring trust, and appreciating differences
  • Strong communication & presentations skills
  • Language : English is required, any additional language is a plus
  • Multi-cultural experience is essential to be able to deal with various cultures globally
  • Willingness to travel min 35%, including global travels
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