Find Regulatory affairs Jobs in Dublin, D

Safety and Regulatory Affairs Officer
Novo Nordisk —Dublin, County Dublin
- €62,560–€100,090 a year
- English
- Project management
- No degree
2d
Senior Compliance Analyst, Compliance & Regulatory Affairs
AXA —DUBLIN 1, County Dublin
- Communication skills
6d
Compliance Analyst, Conduct Risk - 12 month FTC
AXA —DUBLIN 1, County Dublin
- Communication skills
5d
QC/RA Officer
Merit Pharamceuticals —Swords, County Dublin
- From €20,000 a year
- Part-time
- Communication skills
- Time management
Quick apply
1d
CMC Biopharma Regulatory Consultant — Ecolab Life Sciences
Ecolab Inc. —Dublin, County Dublin
- €7,425 a month
- Doctoral degree
- Sales
- English
Principal Consultant - Regulatory Affairs
NNIT A/S —Dublin, County Dublin
- Spanish
- Sales
- English
CMC Biopharma Regulatory Consultant — Ecolab Life Sciences
Ecolab —Dublin, County Dublin
- €7,425 a month
- Doctoral degree
- Sales
- English
Director, Regulatory Affairs
Gilead Sciences —Dublin, County Dublin
- Full-time
- Doctoral degree
- Master's degree
- Analysis skills
Regulatory Affairs & Field Sciences Manager - Europe
Oath —Dublin, County Dublin
- Remote
- Research
- Communication skills
Quick apply
8d
Corporate Governance Graduate Programme 2027 | BDO Ireland LLP Dublin
BDO Ireland —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Annual leave
Quick apply
1d
Medical Governance, Evidence and Operations Lead
Novartis —Dublin, County Dublin
- €75,880–€140,920 a year
- Full-time
- Hybrid work
- English
- Analysis skills
- Bachelor's degree
Director, Regulatory Affairs Medical Devices & Combination Product
Takeda Pharmaceutical —Dublin, County Dublin
- €116,800–€160,600 a year
- Full-time
- English
- Bachelor's degree
- Communication skills
Product Manager - Quality and Regulatory Systems
Life Scientific —Dublin, County Dublin
- Hybrid work
- Product management
Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence
Gilead Sciences —Dublin, County Dublin
- Full-time
- Doctoral degree
- Master's degree
- Analysis skills
Sr. Associate Process Development
Amgen —Dún Laoghaire, County Dublin
- €59,569.70–€80,594.30 a year
- Doctoral degree
- Engineering
- Master's degree
10h
Medical Advisor & Medical Operations Lead
MSD —Leopardstown, County Dublin
- Full-time
- Management
- Doctoral degree
- Master's degree
6d
Associate Director, Precision Medicine (Clinical Diagnostics)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Doctoral degree
- Research
- Annual leave
Corporate Governance Manager
FIS Global —Dublin, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Associate Director, Global Medical Information and Medical Review
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Doctoral degree
- Microsoft Office
- Master's degree
7d
Privacy & AI Counsel
iCims —DUBLIN 2, County Dublin
- Full-time
- Research
- Microsoft Office
- In-person
- Annual leave
- Life insurance

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Safety and Regulatory Affairs Officer

Novo Nordisk -
Dublin, County Dublin

Apply Now

Job details

€62,560–€100,090 a year
2 days ago

Qualifications

English
Project management
Communication skills

Full job description

Safety and Regulatory Affairs Officer

Category: Reg Affairs & Safety Pharmacovigilance

Location: Dublin, Leinster, IE

Safety and Regulatory Affairs Officer

Dublin, Ireland

Take ownership as the Pharmacovigilance Responsible Person for our Irish affiliate and lead regulatory projects that keep life-changing medicines safe, compliant and available to the patients who rely on them. If you thrive at the intersection of science, regulation and patient safety, this is your opportunity to make a tangible difference.

Your new role

In this dual role, you will act as our Pharmacovigilance Responsible Person (PVRP) for Ireland while supporting regulatory affairs activities for Novo Nordisk medicinal products and medical devices on the Irish market.

Day-to-day your tasks will include:

Managing safety case processing, triage, follow-up and expedited reporting (ICSRs, SUSARs, medical device reports, DMC statements) to Global Patient Safety and Customer Complaints, in line with regulations and internal Novo Nordisk requirements

Overseeing PV vendors, reconciliation and QC processes, and maintaining systems such as Veeva Safety, Vault Quality, IO-CCS and HALO PV for Ireland

Drafting and maintaining Safety Data Exchange Agreements (SDEAs), conducting PV training for employees and vendors, and monitoring the safety mailbox and Irish medical journals for reportable information

Leading regulatory submissions, variations, renewals, PSURs and risk minimisation materials, and supporting the lifecycle management of product licences with HQ and regional teams

Ensuring high-quality compliant labelling – including SmPCs, PILs and Abbreviated Prescribing Information – and keeping VaultRIM and regulatory trackers up to date

Interfacing and negotiating with external stakeholders such as HPRA, HSE and IPHA, and providing accurate regulatory advice to internal business units

Supporting activities related to non-compliances, deviations, change requests, stock shortages, parallel trade notifications and audit/inspection readiness

Your new department

As part of International Operations, you will join our largest operational unit. Covering 194 countries and 95% of the world's population, more than 18,000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition, we continue to be the growth driver for Novo Nordisk, and to improve health at scale across the globe.

You will join the Regulatory & Safety team within our Irish affiliate, working closely with colleagues across medical, commercial and customer service, as well as with Headquarters (NN A/S) and regional counterparts. It is a role with real breadth – combining hands-on operational responsibility with strategic influence on how Novo Nordisk products are launched, maintained and communicated in Ireland.

Your skills & qualifications

We are looking for a detail-oriented professional who enjoys working across disciplines and takes pride in getting the compliance details right. You will bring with you:

A 3rd level qualification, preferably a graduate degree in Life Sciences

Relevant industry experience, preferably within pharmacovigilance and/or regulatory affairs, ideally combined with proven success in an ethical pharmaceutical customer-facing role

Solid knowledge of pharmacovigilance systems, regulatory approval processes, labelling requirements and applicable legislation (including the IPHA Code)

Strong project management, planning, prioritisation and organisational skills, with a clear concern for quality and detail

Excellent written and verbal communication skills in English, with the confidence to influence internal stakeholders and negotiate with external authorities such as HPRA, HSE and IPHA

A collaborative, solutions-focused mindset – comfortable embracing change, making decisions and delivering results in a regulated environment

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

Salary: For this role, the Annual Base Salary ranges from €62,560 – €100,090 corresponding to Job Level 6 and the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here.

Deadline

6 September 2026. Applications are reviewed on an ongoing basis, so please apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Apply Now

Refine Your Search

regulatory affairs jobs in dublin, d

Safety and Regulatory Affairs Officer

Senior Compliance Analyst, Compliance & Regulatory Affairs

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QC/RA Officer

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Director, Regulatory Affairs Medical Devices & Combination Product

Product Manager - Quality and Regulatory Systems

Senior Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence

Sr. Associate Process Development

Medical Advisor & Medical Operations Lead

Associate Director, Precision Medicine (Clinical Diagnostics)

Corporate Governance Manager

Associate Director, Global Medical Information and Medical Review

Privacy & AI Counsel

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