Regulatory Affairs Officer

1 month 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.
 

In Viatris we are empowering people worldwide to live healthier at every stage of life can only be achieved through our collective passion. We are committed to seeing healthcare not as it is, but as it should be.

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

Key responsibilities for this role include:

Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues.

Ensure on-time submissions for all safety related changes for assigned projects.

Ensure databases and systems (including D2, GLAMS, MyPortfolio and TrackWise) are updated in-line with current SOPs and up-to-date information is available for all assigned products.

Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance.

Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.

Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.

Prepare regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions with support from Line Manager

Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.

Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.

Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.

The minimum qualifications for this role are:

Minimum of a Bachelor degree in science or in a related science.

Minimum of 2 years of relevant experience in a related role in the pharmaceutical industry. 

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.

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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