Regulatory Affairs Officer

4 weeks ago

Dublin, Ireland Viatris Full time
McDermott Laboratories Limited

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
 

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

Supporting Viatris's mission to provide high quality access to healthcare by assisting senior leaders with compliant registration of established products within one or more product types (OSD, Biologics, Injectables, Transdermal, API, etc.) throughout the product lifecycle within a given region (NA, EU, JA, NZ, ROW etc.).

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Officer role will make an impact:

Provide administrative support to meet general business needs.

Interact in a highly professional manner with Regulatory Affairs team and external departments.

Schedule meetings and facilitate conference calls as requested by management.

Organize travel for management.

Communicate with Health Authorities regarding general administrative tasks (eg. slot dates, fee payments etc.) and other non-technical, non-scientific communications.

Execute regulatory activities, as directed, for product lifecycle management for one or more product types (OSD, Biologics, Injectables, Transdermal, API, etc.) within a specified region (NA, EU, JA, NZ, ROW etc.).

Maintain general knowledge of regulations and guidance for one or more product types (Biologics, OSD, Injectables, API etc.) within a specified region (NA, EU, JA, NZ, ROW etc.).

Collaborate with regulatory team to prepare submission documents.

Collaborate with regulatory team to ensure all documentation is in compliance with eCTD stand

Perform data entry to ensure regional regulatory compliance within regulatory databases and change management system.

Organize and maintain databases for regulatory use as directed by management.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

High school diploma/GED/Higher secondary or equivalent

2-3 years of experience in a clerical or administrative role

Must possess organization skills, time management skills and attention to detail.

Strong demonstrable capabilities in the use of software applications.

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. Some of our benefits include the following on top of a competitive salary:

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

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

At Viatris, we offercompetitivesalaries, benefitsandan 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.

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