Senior Manager, Global Regulatory Affairs – Business Process

Viatris; Dublin; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Excellent career progression opportunities

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a professional in Dublin, Ireland, to lead the design and optimization of regulatory processes. The role requires experience in Regulatory Affairs and project management within highly regulated industries. The candidate will collaborate with cross-functional teams to ensure compliance and enhance processes. Benefits include health insurance, a bonus scheme, and excellent career progression opportunities.

Qualifications

• Experience in a Regulatory Affairs function within Pharmaceutical, Biotech, or other regulated industries.
• Previous experience in process design and project management.
• Must have a compliance background.
• Comprehensive knowledge of policies, procedures, and systems.

Responsibilities

• Lead design and optimization of processes for regulatory organization.
• Collaborate with cross-functional teams on regulatory systems.
• Establish SME networks and lead continuous improvement initiatives.

Skills

Regulatory Affairs experience

Process design

Project management

Compliance knowledge

Data analytics

Education

Six Sigma or project management certification

Tools

Visio

Job description

Responsibilities

Process Optimization and Design

• 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.

Regulatory Process Adherence Oversight

• Involve cross‐functional colleagues and partner on development and monitoring of regulatory process adherence oversight.
• Close collaboration with other Regulatory functions, as appropriate, on training and communications of new processes and continuous improvements.
• Share awareness of and insight in authorities’ inspections and internal audits of regulatory processes, including outcome and findings in the area of responsibility; support of CAPA related activities for regulatory and cross‑functional alignment.
• Utilize data analytics/metrics to provide an understanding of data flow and trends leading to identification of process improvements.

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.

Benefits

• Excellent career progression opportunities
• Work‑life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Viatris is an Equal Opportunity Employer.