Regulatory CMC Lead – Global Site Transfers & API Sourcing

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Bonus scheme

Health insurance

Pension

Work-life balance initiatives

Excellent career progression opportunities

Job summary

Mylan Pharmaceuticals Inc. is seeking a Director Regulatory CMC Sciences Project Management in Dublin, Ireland. This senior-level role involves oversight for complex manufacturing transfers and regulatory project management for global initiatives. Candidates should have substantial CMC authoring experience, advanced regulatory knowledge, and exceptional communication abilities. This position offers competitive salaries and benefits, including career progression opportunities, health insurance, and work-life balance initiatives.

Qualifications

• Mandatory hands-on CMC authoring experience for registrations and variations.
• Proven capability in managing complex regulatory projects.
• Extensive knowledge of post-approval variations for site transfers.

Responsibilities

• Provide regulatory project management support for global network optimization.
• Cultivate effective relationships with internal stakeholders for regulatory assessments.
• Develop dashboards and metrics for reporting to stakeholders.

Skills

Regulatory project management

Complex project management

Excellent communication skills

Stakeholder management

Technical knowledge

Education

Degree in relevant field (Pharmacy, Life Sciences)

Tools

Microsoft Office Suite

Documentum-based applications

Job description

Mylan Pharmaceuticals Inc. is seeking a Director Regulatory CMC Sciences Project Management in Dublin, Ireland. This senior-level role involves oversight for complex manufacturing transfers and regulatory project management for global initiatives. Candidates should have substantial CMC authoring experience, advanced regulatory knowledge, and exceptional communication abilities. This position offers competitive salaries and benefits, including career progression opportunities, health insurance, and work-life balance initiatives.