Find Chain pharmaceutical Jobs in Dublin, D

Senior Regulatory Affairs Officer (12 Month FTC)
Viatris —Northern Cross, County Dublin
- Full-time
- Bachelor's degree
- Time management
Field Service Technician Mechatronic Ireland & UK
Körber AG —Dublin, County Dublin
- English
- No degree
- Mechanical knowledge
Facilities and Sustainability Manger
United Drug —Citywest, County Dublin
- Full-time
- Project management
- Bachelor's degree
- Communication skills
- Employee assistance program
- Employee discount
Quick apply
Operations Supervisor
Uniphar Wholesale Limited —DUBLIN 24, County Dublin
- Weekend availability
- Microsoft Excel
- Analysis skills
- Computer skills
Quick apply
OTC Sales Assistant
McCabes Pharmacy —Clondalkin, County Dublin
- Full-time
- Employee assistance program
- Employee discount
Quick apply
2d
Associate Director, Supply Chain Business Support (Remote / Home Based)
Jazz Pharmaceuticals —Dublin, County Dublin
- Engineering
- Business
- Communication skills
- Annual leave
Manager, Supply and Logistics
Tonix Pharmaceuticals Inc —Dublin, County Dublin
- Full-time
- Remote
- Microsoft Excel
- ERP systems
- Bachelor's degree
- Annual leave
- Employee assistance program
Quick apply
Field Service Engineer
Körber AG —Dublin, County Dublin
- English
- Analysis skills
- Communication skills
Health and Safety Officer
United Drug —Citywest, County Dublin
- Full-time
- Organisational skills
- IT
- Employee assistance program
Quick apply
Project Manager
PSC Biotech —Dunboyne, County Meath
- Full-time
- Engineering
- Master's degree
- Project management
3d
ServiceNow Administrator ( UK & Ireland )
Uniphar PLC —DUBLIN 24, County Dublin
- Full-time
- Scripting
- Communication skills
Quick apply
GMDP Quality Assurance Manager
WEP Clinical —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Senior Director, Head of Global S&OP & Resilience
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Sales
- Master's degree
- Bachelor's degree
EHS Specialist 3
APC Ltd —Dublin, County Dublin
- Full-time
- Hybrid work
- Research
Quick apply
7d
Director Regulatory Affairs Global CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- Mentoring
- Manufacturing
SAP EWM Specialist, Hybrid
Deloitte —Dublin, County Dublin
- €55,000 a year
- Full-time
AI Lead, Manufacturing & Supply Chain
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Computer Science
- Master's degree
- Bachelor's degree
Pharmacy Technician - Rotational (Fixed Term Contract)
Beacon Hospital —Dublin, County Dublin
- Weekend availability
Quick apply
1d
Pharmacy Technician
McCabes Pharmacy —Sandyford, County Dublin
- Full-time
- No degree
- Higher certificate
- Employee assistance program
- Employee discount
Quick apply
Stock Controller
United Drug —Citywest, County Dublin
- Weekend availability
- Microsoft Excel
- Microsoft Outlook
- Sales
- Employee assistance program
- Employee discount
Quick apply
7d

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Senior Regulatory Affairs Officer (12 Month FTC)

Viatris -
Northern Cross, County Dublin

Apply Now

Job details

Full-time

Qualifications

Bachelor's degree
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

Obtain and maintain marketing authorisations for products in designated EU territories (internal and 3rd Party / BD). Perform any other regulatory activities as required by company strategy.

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

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.
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.
Embrace the One Team approach across all Regional Submission Teams by ensuring
consolidation of worksharing activities in line with Senior Management guidance, for example increased sharing of expertise and knowledge, combined meetings and collaboration on initiatives and working groups.
Support the Line Manager by participating in project teams to support departmental initiatives.
Provide mentoring and training to (Associate) Regulatory Officers and/or (Senior) Regulatory Assistants as directed by Line Manager.
On an ad hoc basis, carry out additional tasks on behalf of Principal Registration Officer/(Senior) Regulatory Manager.

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:

Bachelor's degree or equivalent in Science/Technology/ Pharmacy
Experience In Regulatory/Quality/R&D
Capable of understanding health authority expectations for pharmaceutical types for a specified region.
Strong demonstrable capabilities in the use of software applications.
Must possess organization skills, time management skills and attention to detail.

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

chain pharmaceutical jobs in dublin, d

Senior Regulatory Affairs Officer (12 Month FTC)

Field Service Technician Mechatronic Ireland & UK

Facilities and Sustainability Manger

Operations Supervisor

OTC Sales Assistant

Associate Director, Supply Chain Business Support (Remote / Home Based)

Manager, Supply and Logistics

Field Service Engineer

Health and Safety Officer

Project Manager

ServiceNow Administrator ( UK & Ireland )

GMDP Quality Assurance Manager

Senior Director, Head of Global S&OP & Resilience

EHS Specialist 3

Director Regulatory Affairs Global CMC

SAP EWM Specialist, Hybrid

AI Lead, Manufacturing & Supply Chain

Pharmacy Technician - Rotational (Fixed Term Contract)

Pharmacy Technician

Stock Controller

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