Manager Corporate Drug Regulatory Affairs (Maternity Cover – ETW)

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Generics U.K. Ltd.

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

Manager Corporate Drug Regulatory Affairs responsible to support the pharmaceutical-regulatory of the assigned medicinal products and products worldwide. The jobholder is bound to the instructions of the responsible Team leader of Corporate Drug Regulatory Affairs.

Key Responsibilities

Every day we rise to the challenge to make a difference and heres how the Manager Corporate Drug Regulatory Affairs role will make an impact:

Handling of marketing authorisation application procedures (e.g. new submissions line extensions) worldwide as well as registration maintenance activities (e.g. variations renewals)
Preparation and discussion of licensing strategies with national and international authorities
Collaboration in regional / global projects in Cross functional teams
Review preparation coordination and processing of regulatory documents (CTD-module 1)
Review and coordination of quality documentation (CTD module 3 / 2.3)
Coordination of clinical and non-clinical documentation
Support of QA activities (e.g. change control PQR) drug information and
pharmacovigilance related activities (e.g. Risk Management Plans Company Core Data Sheets PSURs)
Use of electronic systems like Documenten management system Change Control System Regulatory Information Management System etc.

About Your Skills & Experience

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

University degree in natural sciences i.e. Biology Chemistry or Pharmacy
At least 3 years of experience in regulatory affairs
Knowledge of essential regulatory requirements
Ability to plan and execute regulatory projects globally
Excellent communication skills a real team player
Excellent skills in English language
Knowledge in standard EDV programs (e.g. MS-Office)
Preferrable knowledge in common regulatory systems (e.g. DMS CCS RIMS)

At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your experience doesnt fully align with every requirement we still encourage you to apply. You may just be the right candidate for this or other roles.

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 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 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.

Required Experience:

Manager

Generics U.K. Ltd.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 Provid...