Senior Manager, Global Regulatory Affairs – Business Process

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

McDermott Laboratories Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Global Regulatory Affairs - Business Process role will make an impact:

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.

About Your Skills & Experience

• 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

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

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

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.