Global Regulatory Process Leader — Compliance & Optimization

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 110,000 - 150,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Senior Manager, Global Regulatory Affairs - Business Process to lead design, development and optimization of regulatory processes across the organization. You will work with cross-functional teams responsible for regulatory workflows and ensure systems alignment.

The role requires experience in Regulatory Affairs within pharma/biotech, plus process design, project management and compliance knowledge.

Qualifications

• Experience in a Regulatory Affairs function within Pharmaceutical, Biotech, or other highly regulated industries required.
• Previous experience in process design and project management preferred.
• Compliance background preferred.
• Comprehensive knowledge of departmental and organizational policies, procedures and systems
• Six Sigma or other project management certification preferred
• Basic flowcharting skills (e.g. Visio) preferred

Responsibilities

• Lead the design, development, implementation and optimization of processes for the regulatory organization.
• Work with cross-functional teams responsible for processes involving regulatory responsibility across the organization; provide oversight and alignment on regulatory systems and interdependencies; contribute to communication and training relating to Regulatory process development.
• Establish SME networks and lead pilots and outcome learnings; Obtain ideas from stakeholders for system and/or process improvement; Close collaboration with GRA Compliance, L&D, Metrics teams, and SMEs team to identify opportunities for continuous improvement.
• Involve cross functional colleagues and partner on development and monitoring of regulatory process adherence oversight.

Skills

Regulatory affairs

Process design

Compliance

Policies & procedures

Six Sigma

Visio

Tools

Visio

Job description

Viatris is seeking a Senior Manager, Global Regulatory Affairs - Business Process to lead design, development and optimization of regulatory processes across the organization. You will work with cross-functional teams responsible for regulatory workflows and ensure systems alignment.

The role requires experience in Regulatory Affairs within pharma/biotech, plus process design, project management and compliance knowledge.