Senior Regulatory Affairs Chemistry Manufacturing Leader

2 semanas atrás


Lisboa, Lisboa, Portugal Organón Tempo inteiro

Company Overview: Organon is a leading pharmaceutical company dedicated to improving human health. We are committed to delivering innovative solutions that meet the evolving needs of our customers and patients.

Salary: $120,000 - $180,000 per year, depending on experience and qualifications.

Job Description:

The Position

We are seeking an experienced Senior Regulatory Affairs Chemistry Manufacturing Leader to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory CMC support for Organon Network Projects. This includes overseeing preparation and submission of CMC dossiers for assigned Network Projects, managing processes and connections between external partners and stakeholders, and cultivating collaborative relationships with internal and external partners.

Responsibilities:

  • Manage preparation and submission of Global CMC dossiers for assigned Network projects
  • Oversight of assigned CMC project timelines
  • Cultivate and foster collaborative relationships with internal and external partners
  • Active monitoring, facilitation, reporting, and communication of progress against agreed timelines
  • Escalate potential delays or performance issues in a timely manner
  • Manage communication and change management within the organization
  • Provide CMC support for Legal Entity Change (LEC) project

Required Skills and Qualifications:

  • Bachelor's degree in a science, engineering, or a related field
  • Minimum 7 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related field
  • Strong negotiation, interpersonal, written/oral communication skills
  • Fluent in English language
  • Ability to lead by influence and work effectively in matrix organizational structures
  • Project Management skills

Benefits:

  • Competitive salary and benefits package
  • Opportunities for career growth and professional development
  • A dynamic and supportive work environment

Others:

Organon is an equal opportunities employer and welcomes applications from diverse candidates. If you are passionate about regulatory affairs and have a strong background in CMC strategy, please submit your application.



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