Find regulatory affairs Jobs in dublin, d

Manager Corporate Drug Regulatory Affairs (12 month agency contract)
Viatris —Northern Cross, County Dublin
- Full-time
- English
- Bachelor's degree
- Communication skills
Manager, Regulatory Affairs
Azurity Pharmaceuticals - Ireland —Dublin, County Dublin
- English
- Bachelor's degree
- Communication skills
Manager, Regulatory Affairs
Azurity Pharmaceuticals - US —Dublin, County Dublin
- English
- Bachelor's degree
- Communication skills
Sr Dir CMC Regulatory Affairs
Regeneron —Dublin, County Dublin
- Bachelor's degree
- In-person
- Leadership
- Annual leave
12d
Head of Global Regulatory Affairs Strategy
Viatris —Northern Cross, County Dublin
- Full-time
- Doctoral degree
- Master's degree
- Business
7d
Director Regulatory Affairs Global CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- Mentoring
- Manufacturing
Assistant Manager, Regulatory Affairs CMC (Global)
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Manufacturing
Global Regulatory Exams and Inquiries Officer
Bloomberg —Dublin, County Dublin
- Finance
- Master's degree
- Bachelor's degree
Senior Manager, Regulatory Affairs CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
Senior Manager, European Regulatory Policy and Intelligence
Viatris —Northern Cross, County Dublin
- Full-time
- Communication skills
- Marketing
7d
Senior Manager, Global Regulatory Affairs – Business Process
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- No degree
Patient Safety Partner
Roche —Dublin, County Dublin
- Nursing
- Master's degree
- Bachelor's degree
13d
Board Governance Administrator
Mercer —Dublin, County Dublin
- Full-time
- Microsoft Office
- Administrative experience
- No degree
Exams Manager
Dublin Business School —Dublin, County Dublin
- €50,000 a year
- Weekend availability
- Microsoft Excel
- Microsoft Office
- Organisational skills
- Employee assistance program
- Employee discount
1d
Quality Complaint & Recall Administrator
Exertis —Leopardstown, County Dublin
- Organisational skills
- Communication skills
1d
Radio Producer – Radio 1
RTÉ —Dublin, County Dublin
- €54,661–€85,602 a year
- Part-time
- Leadership
- Communication skills
5d
Senior Specialist Regulatory Key Initiatives
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- Bachelor's degree
Senior Specialist Regulatory Operations (Electronic Submissions)
Viatris —Northern Cross, County Dublin
- Full-time
- Marketing
- English
- Microsoft Office
- Employee assistance program
Director Regulatory Compliance (Process Excellence)
Viatris —Northern Cross, County Dublin
- Full-time
Director Respiratory Regulatory CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
- Manufacturing

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Manager Corporate Drug Regulatory Affairs (12 month agency contract)

Viatris -
Northern Cross, County Dublin

Apply Now

Job details

Full-time

Qualifications

Biology
English
Bachelor's degree
Communication skills

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

Every day, we rise to the challenge to make a difference and here’s 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, we’re 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
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 of 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 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.

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

regulatory affairs jobs in dublin, d

Manager Corporate Drug Regulatory Affairs (12 month agency contract)

Manager, Regulatory Affairs

Manager, Regulatory Affairs

Sr Dir CMC Regulatory Affairs

Head of Global Regulatory Affairs Strategy

Director Regulatory Affairs Global CMC

Assistant Manager, Regulatory Affairs CMC (Global)

Global Regulatory Exams and Inquiries Officer

Senior Manager, Regulatory Affairs CMC

Senior Manager, European Regulatory Policy and Intelligence

Senior Manager, Global Regulatory Affairs – Business Process

Patient Safety Partner

Board Governance Administrator

Exams Manager

Quality Complaint & Recall Administrator

Radio Producer – Radio 1

Senior Specialist Regulatory Key Initiatives

Senior Specialist Regulatory Operations (Electronic Submissions)

Director Regulatory Compliance (Process Excellence)

Director Respiratory Regulatory CMC

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