Find Manager in training life science Jobs in Dublin 22, D

Senior Regulatory Affairs Officer (12 Month FTC)
Viatris —Northern Cross, County Dublin
- Full-time
- Bachelor's degree
- Time management
Site Manager
Cunningham Contracts —DUBLIN 22, County Dublin
- Full-time
- Construction Management
- Communication skills
- Annual leave
- Employee assistance program
Quick apply
13d
Project Engineer
Turner & Townsend —Dublin, County Dublin
- Full-time
- Microsoft Office
- Leaving certificate
- Project management
Quick apply
5d
EHR Systems Analyst
UPMC —Dublin, County Dublin
- Clinic
- IT
- Annual leave
Programmatic Manager
Core —Dublin, County Dublin
- €33,000–€44,000 a year
- Weekend availability
- Hybrid work
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Office
- Annual leave
- Employee assistance program
Quick apply
6d
Groundworker
Cunningham Contracts —DUBLIN 22, County Dublin
- Full-time
- Construction experience
Quick apply
13d
Data Steward, Re:Cycle Reverse Logistics
Re:Cycle Reverse Logistics Ireland Limited —Dublin, County Dublin
- Full-time
- Computer Science
- SQL
- AWS
Software Development Engineer
Amazon Development Centre Ireland Limited —Dublin, County Dublin
- Full-time
- Computer Science
- AWS
- Bachelor's degree
Account Manager, Endoscopy (Dublin)
Boston Scientific —Dublin, County Dublin
- Microsoft Excel
- Negotiation
11d
Business Unit Head of Commissioning
Mercury Engineering —Dublin, County Dublin
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Software Engineer
iCIMS Talent Acquisition —DUBLIN 2, County Dublin
- Full-time
- Remote
- Bachelor's degree
- JavaScript
- Communication skills
- Annual leave
- Life insurance
Senior Success Architect- Health and life Sciences Industry
Salesforce —Dublin, County Dublin
- Full-time
- Salesforce
- English
- Communication skills
Sales & Services Assistant
Hines —Dublin, County Dublin
- Weekend availability
Client Engagement & CRM Manager
Sia —DUBLIN 2, County Dublin
- Full-time
- English
- Analysis skills
Quick apply
Financial Planning & Analysis Lead (Manager) - French Speaking
Salesforce —Dublin, County Dublin
- Full-time
- Computer Science
- Sales
- Engineering
Principal, Global Feasibility (pre-award strategy) - Sponsor-dedicated - EMEA
サイネオス・ヘルス —Dublin, County Dublin
- Doctoral degree
- Research
- Master's degree
Integration & Commissioning Manager
Thermo Systems LLC —Dublin, County Dublin
- Full-time
- Engineering
- Annual leave
Quick apply
3d
Mechanical Workshop Manager
CEC —Leixlip, County Kildare
- Full-time
- CAD
- Project management
- Team management
Quick apply
3d
Director of Project Management
IPS-Integrated Project Services —DUBLIN 12, County Dublin
- Full-time
- Engineering
- Project management
- Bachelor's degree
13d
AI Implementation Programme Manager
Expleo —Dublin, County Dublin
- Azure
- Computer Science
- Project management
2d

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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

manager in training life science jobs in dublin 22, d

Senior Regulatory Affairs Officer (12 Month FTC)

Site Manager

Project Engineer

EHR Systems Analyst

Programmatic Manager

Groundworker

Data Steward, Re:Cycle Reverse Logistics

Software Development Engineer

Account Manager, Endoscopy (Dublin)

Business Unit Head of Commissioning

Software Engineer

Senior Success Architect- Health and life Sciences Industry

Sales & Services Assistant

Client Engagement & CRM Manager

Financial Planning & Analysis Lead (Manager) - French Speaking

Principal, Global Feasibility (pre-award strategy) - Sponsor-dedicated - EMEA

Integration & Commissioning Manager

Mechanical Workshop Manager

Director of Project Management

AI Implementation Programme Manager

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