Director Global Regulatory Compliance (Process Excellence)

Viatris; Dublin; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Career progression opportunities

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is looking for a Director of Regulatory Compliance to spearhead the Global Regulatory Affairs Compliance function. This role involves overseeing compliance operations and ensuring adherence to regulatory processes while developing the GRA Quality Management System.

The ideal candidate should possess strong leadership experience in a complex pharmaceutical environment, demonstrating their ability to collaborate with cross-functional teams. Vitasris offers excellent career progression, health insurance, and work-life balance initiatives.

Qualifications

• Engaged leader with experience in audit and inspection in a European market.
• Knowledgeable in pharmaceutical industry compliance.
• Proven ability to partner with other regulatory functions and teams.

Responsibilities

• Build and lead the Global Regulatory Affairs Compliance function.
• Monitor adherence to regulatory processes and lead inspection readiness.
• Develop and evolve the GRA Quality Management Systems.

Skills

Leadership in GRA compliance

Interpersonal and strategic influencing

Collaboration in a matrix environment

Job description

Meda Pharma GmbH & Co KG

Director, Regulatory Compliance

Build and lead a newly established Global Regulatory Affairs (GRA) Compliance function, responsible for defining, embedding and continuously improving compliance across GRA. Partner closely with cross‑functional stakeholders to monitor adherence to regulatory processes, lead audit and inspection readiness, and own the development and evolution of the GRA Quality Management System (QMS).

Compliance

• Leadership and oversight on GRA compliance related topics, inspection & audit outcomes and trending.
• Provision and as needed escalation of GRA compliance related topics to Senior Leaders.
• Oversight of authorities’ inspections and internal audits of GRA, including outcome & findings monitoring; tracking and monitoring of QE/CAPA related activities for GRA.
• Strong support in compiling and collecting information presented to auditors.
• Collaboration with cross‑functional teams related to compliance in and outside GRA.

Quality Management System (QMS)

• Develop and evolve the GRA Quality Management Systems (QMS), including GRA process hierarchy, procedure design, review and approval process, regular risk assessments, maintenance of a GRA Quality Plan, oversight of management review of systems and a high‑level definition of GRA roles and responsibilities.

Regulatory Process Adherence Oversight

• Oversight of GRA controlled documents and review/approval of new GRA procedures.
• Monitoring process adherence in GRA, including cross‑functional involvement and strategic partnership on all aspects related to regulatory process adherence oversight.
• Oversight on procedures owned outside GRA where regulatory is listed in the responsibility section and/or being trained on.
• Close collaboration with the extended leadership team on all compliance and process adherence related topics, review and input into curricula and support for evaluation of training needs throughout GRA.

About Your Skills & Experience

• Engaged leader with demonstrable experience of effective delivery in a complex matrix and multi‑national environment and experienced in audit and inspection conduct in a European market.
• Knowledgeable and engaged in all matters related to compliance in the pharmaceutical industry.
• Collaborative team player with excellent interpersonal and strategic influencing and cross‑functional working skills.
• Proven ability to partner successfully with other Regulatory functions, Quality, Safety, Medical and other internal stakeholders to achieve objectives.

Benefits

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

Viatris is an Equal Opportunity Employer. For diversity, equity and inclusion information, visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion. For sustainability information, visit https://www.viatris.com/en/about-us/corporate-responsibility.