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Assistant Manager, GRA Business Process

Posted 26 days 8 hours ago by 1100 Mylan Pharmaceuticals Inc.

Permanent
Full Time
Other
Dublin, Ireland
Job Description
About Viatris

Viatris is a global healthcare company that provides high quality medicines to patients worldwide. It was formed in 2020 through the combination of Mylan and Upjohn and is committed to access, education, outreach and better treatment by creating healthier communities.

Role & What You Will Be Doing

Assistant Manager, GRA Business Process.

Support the Global Regulatory Affairs (GRA) Business Processes team in developing, optimizing and implementing business processes. Draft Standard Operating Procedures (SOPs), Work Instructions (WIs), Job Aids (JAs) and Quick Reference Guides (QRGs) that translate complex regulatory processes into clear, user friendly guidance for global teams.

Responsibilities
  • Develop high quality SOPs, WIs, JAs and QRGs supporting global regulatory processes, ensuring clarity and alignment with controlled document standards.
  • Draft new business processes based on SME input, process maps, regulatory requirements, internal references and system workflows.
  • Participate in process design meetings, system demonstrations and workflow reviews.
  • Incorporate diagrams, screenshots, process flows and visual elements to enhance usability.
  • Partner with GRA Compliance, Learning & Development, Metrics teams and SMEs to support communications and training related to regulatory process development.
  • Coordinate review and approval in D2 for developed regulatory business processes.
  • Maintain documentation repositories, version control and update cycles in line with GRA governance.
  • Identify documentation gaps, redundancies and opportunities for simplification using data and stakeholder feedback.
  • Support development and monitoring of regulatory process adherence oversight.
  • Conduct periodic reviews to keep content current with evolving systems, regulations and processes.
  • Support maintenance of regulatory business process webpages.
Skills & Experience
  • Experience in a Regulatory Affairs function within pharmaceutical, biotech, medical device or another highly regulated industry.
  • Proven ability to draft SOPs, WIs, JAs and QRGs with strong process documentation, workflow analysis and information design skills.
  • Experience using electronic document routing and workflow platforms for controlled document processes.
  • Excellent writing, editing and communication skills focused on clarity, compliance and usability for global audiences.
  • Proficiency with documentation tools such as SharePoint, SnagIt, Visio, Documentum or similar.
  • Ability to manage multiple projects in a fast paced, global environment.
  • Previous experience in process design and project management preferred.
  • Strong knowledge of departmental and organizational policies, procedures and systems.
  • Basic flowcharting skills (e.g., Visio) preferred.
Benefits
  • Competitive salary.
  • Health insurance.
  • Pension.
  • Bonus scheme.
  • Career progression opportunities.
  • Work life balance initiatives.
  • Inclusive work environment.
Diversity & Inclusion

Viatris is committed to building a diverse, inclusive and authentic workplace. We encourage all candidates to apply if their experience aligns with the role.

Sustainability

Corporate social responsibility and sustainability are core to Viatris. Learn more at

Equal Opportunity Employer

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status or any other protected status.

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