Find Senior specialist regulatory operations and system support Jobs in Ireland

Senior Specialist Regulatory Operations and System Support
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Senior Specialist Regulatory Operations (Electronic Submissions)
Viatris —Northern Cross, County Dublin
- Full-time
- Marketing
- English
- Microsoft Office
- Employee assistance program
OEM Automation Lead – Senior Specialist, Dundalk - Hybrid
MSD —Dundalk, County Louth
- Full-time
- Hybrid work
- Engineering
- System design
- No degree
Operational Controls Senior specialist
Intesa Sanpaolo Group —Dublin, County Dublin
- Microsoft Excel
- English
- SQL
Senior Specialist, Credit Services Administration
The Bank of New York Mellon Corporation —Dublin, County Dublin
- Full-time
- Microsoft Excel
- Bachelor's degree
- Accounting
Operational Excellence Specialist
Haleon —Dungarvan, County Waterford
- €45,841.00–€63,031.10 a year
- Full-time
- Engineering
- Project management
- Presentation skills
7d
Funds Onboarding specialist
Apex Group —Limerick, County Limerick
- Full-time
- Hybrid work
- English
- Master's degree
- Bachelor's degree
AML/KYC Quality Control and Testing Specialist
Northern Trust Corp. —Limerick, County Limerick
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Senior Quality System Specialist (Maternity leave cover) Remote / Home Based
Jazz Pharmaceuticals —Dublin, County Dublin
- Engineering
- Bachelor's degree
- Continuous improvement
- Annual leave
8d
Depositary Services – Supervisor/Senior Analyst (Grade 7)
Brown Brothers Harriman —Dublin, County Dublin
- Full-time
- Microsoft Excel
- Microsoft Office
- Finance
Senior EHS Specialist
APC Ltd —Dublin, County Dublin
- Full-time
- Hybrid work
- Leadership
- Communication skills
Quick apply
Senior Specialist Regulatory Key Initiatives
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
EHR Clinical Build Team Member
UPMC —Kilkenny, County Kilkenny
- Nursing
- Oracle
- Clinic
- Annual leave
12d
Senior Specialist, Commercial Stability
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Microsoft Excel
- Microsoft Office
- Presentation skills
8d
Manufacturing Materials Specialist
WuXi Biologics —Dundalk, County Louth
- Doctoral degree
- Master's degree
- Presentation skills
Data Governance Manager
Cover-More —Blanchardstown, County Dublin
- €100,000 a year
- Full-time
- Continuous improvement
- Communication skills
- Employee assistance program
Quick apply
8d
Senior Specialist, Commercial Stability
AstraZeneca —Dublin, County Dublin
- Microsoft Excel
- Microsoft Office
- Presentation skills
8d
Senior Accounts Receivable Billing Specialist
Geotab —Dublin, County Dublin
- Full-time
- Hybrid work
- Finance
- Bachelor's degree
- No degree
7d
Senior Housing and Development Lead
Depaul —Dublin, County Dublin
- €73,065 a year
- Holidays
- Hybrid work
- Leadership
- Communication skills
- Negotiation
- Annual leave
- Employee assistance program
Quick apply
6d
Reconciliation Technology Specialist, Delivery Manager, VP
Sumitomo Mitsui Banking Corporation —Dublin, County Dublin
- €72,000–€134,000 a year
- Hybrid work
- Contracts
- Communication skills
- Annual leave

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Senior Specialist Regulatory Operations and System Support

Viatris -
Northern Cross, County Dublin

Apply Now

Job details

Full-time

Qualifications

Microsoft Office
Master's degree
Bachelor's degree
Document management systems
Adobe Acrobat
Time management

Full 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

The Senior Specialist Regulatory Operations and System Support will support the coordination and management of regulatory documentation and XEVMPD/IDMP submissions to health authorities. Working closely with the central organisation and local affiliates, the role involves tracking registration activities, managing submission status reporting, and ensuring both internal business needs and regulatory authority requirements are met. The successful candidate will also contribute to regulatory systems projects aimed at driving efficiency and effectiveness, while supporting broader project management activities under the direction of the project lead.

Every day, we rise to the challenge to make a difference and here’s how the Senior Specialist Regulatory Operations and System Support role will make an impact:

Maintain xEVMPD (Article 57) data utilising XEVMPD software, ensuring data quality and compliance with submission timelines when submitting to Health Authorities.
Respond to EMA and other Health Authority queries relating to xEVMPD/IDMP data in a timely and accurate manner.
Provide registration tracking input in line with external and internal regulatory requirements and processes.
Coordinate regular communication with MA Coordinators and/or third parties to ensure outstanding actions are completed on time and in accordance with regulatory requirements.
Support XEVMPD system administration, including user management and system updates.
Perform reconciliation of xEVMPD/IDMP data with affiliates as required.
Monitor regulatory requirement updates and contribute to their implementation into relevant systems and processes.
Manage SPOR PMS data submissions and maintain the existing product portfolio within the system.

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:

Minimum of a Bachelor's degree (or equivalent) in a relevant discipline, with 2–4 years of relevant experience; a combination of education and experience will be considered.
Strong knowledge of EU regulations, specifically relating to Article 57(2), SPOR, and IDMP.
Proven expertise in xEVMPD data submissions, associated systems, and regulatory requirements.
Experience working with Regulatory Information Management Systems (RIMS).
Proficiency with Document Management Systems (DMS) and tools including Adobe Acrobat and the Microsoft Office Suite.
Experience engaging with health authorities and stakeholders outside of own functional area.
Demonstrated ability to work collaboratively as part of a team across multiple functions and projects.
Strong time management skills with the ability to prioritise and deliver within defined timelines.
Ability to quickly learn and adapt to new technologies and systems.
Proficient in numerical tasks including the calculation of percentages, ratios, and rates

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 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.

Apply Now

Refine Your Search

senior specialist regulatory operations and system support jobs in ireland

Senior Specialist Regulatory Operations and System Support

Senior Specialist Regulatory Operations (Electronic Submissions)

OEM Automation Lead – Senior Specialist, Dundalk - Hybrid

Operational Controls Senior specialist

Senior Specialist, Credit Services Administration

Operational Excellence Specialist

Funds Onboarding specialist

AML/KYC Quality Control and Testing Specialist

Senior Quality System Specialist (Maternity leave cover) Remote / Home Based

Depositary Services – Supervisor/Senior Analyst (Grade 7)

Senior EHS Specialist

Senior Specialist Regulatory Key Initiatives

EHR Clinical Build Team Member

Senior Specialist, Commercial Stability

Manufacturing Materials Specialist

Data Governance Manager

Senior Specialist, Commercial Stability

Senior Accounts Receivable Billing Specialist

Senior Housing and Development Lead

Reconciliation Technology Specialist, Delivery Manager, VP

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