Find regulatory cmc Jobs in dublin county dublin

Sr Dir CMC Regulatory Affairs
Regeneron —Dublin, County Dublin
- Bachelor's degree
- In-person
- Leadership
- Annual leave
12d
Assistant Manager, Regulatory Affairs CMC (Global)
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Manufacturing
Director Regulatory Affairs Global CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- Mentoring
- Manufacturing
Senior Manager, European Regulatory Policy and Intelligence
Viatris —Northern Cross, County Dublin
- Full-time
- Communication skills
- Marketing
7d
Director Regulatory CMC Sciences Project Management
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
- Mentoring
Director Respiratory Regulatory CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
- Manufacturing
Senior Manager, Regulatory Affairs CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
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
7d
Digital CMC Consultant (Life Sciences)
QbDVision, Inc. —Dublin, County Dublin
- Full-time
- Remote
- Analysis skills
- Bachelor's degree
- No degree
- Annual leave
- Work from home
Quick apply
Project Scheduler - CMC
Sia —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Project management
- Bachelor's degree
Quick apply
CMC Lead, Launch Product, Small Molecules
Takeda Pharmaceutical —Dublin, County Dublin
- €116,800–€160,600 a year
- Full-time
- Engineering
- Project management
- Bachelor's degree
Technical Project Manager -CMC
Sia —Dublin, County Dublin
- Full-time
- Hybrid work
- Doctoral degree
- Engineering
- English
Quick apply
Associate Director, Global Sourcing - External Manufacturing
AstraZeneca —Dublin, County Dublin
- Hybrid work
- Project management
- Bachelor's degree
- No degree
14d
Director, CMC Drug Substance Manufacturing
Olema Oncology —Dublin, County Dublin
- Doctoral degree
- Master's degree
- Project management
Quick apply
Senior Technical Project Manager - CMC
Sia —Dublin, County Dublin
- Full-time
- Hybrid work
- Doctoral degree
- Engineering
- English
Quick apply
Associate Director, Global Sourcing - External Manufacturing
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Hybrid work
- Project management
- Bachelor's degree
- No degree
14d
Manager, External Manufacturing and Supply
Cytokinetics —Dublin, County Dublin
- Engineering
- ERP systems
- Bachelor's degree
Associate Director, External Manufacturing and Supply
Cytokinetics —Dublin, County Dublin
- Engineering
- ERP systems
- Bachelor's degree

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Sr Dir CMC Regulatory Affairs

Regeneron -
Dublin, County Dublin

Apply Now

Job details

12 days ago

Benefits

Annual leave

Qualifications

Bachelor's degree
Leadership

Full job description

We are looking for a leader to guide our CMC & Combination Products regulatory team, supporting a global portfolio of drug and device products with a strong focus on the European Union. In this role, we work closely across functions to shape clear regulatory strategies that support development and keep submissions moving forward. You’ll play a central role in connecting teams, guiding decisions, and ensuring global regulatory alignment.

A Typical Day:

Leading a team delivering CMC and combination product regulatory activities
Shaping global regulatory strategies, with focus on EU requirements
Advising senior leaders on regulatory direction and key considerations
Overseeing submissions and resolving complex compliance issues
Working closely with regulators, partners, and external organisations
Monitoring new regulations and assessing impact on the portfolio
Improving processes and identifying more efficient ways of working
Supporting team development through coaching and regular feedback

This Role May Be For You If You:

Enjoy leading teams and helping others grow in their roles
Like setting direction while staying close to the detail
Are comfortable working with senior stakeholders across functions
Prefer a mix of strategic thinking and hands-on problem solving
Build strong, steady relationships with external partners and regulators
Stay organised when handling multiple priorities at once
Look for practical, simple ways to improve how work gets done
Value clear, direct communication and keeping people aligned

To be considered, you should bring substantial experience in regulatory affairs with a focus on CMC and/or combination products, including developing and guiding global regulatory strategies. A bachelor’s degree is required (an advanced degree is strongly preferred). You should have experience leading teams, working with senior stakeholders, and a strong understanding of EU regulatory requirements. Experience supporting global submissions is essential.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Apply Now

Refine Your Search

regulatory cmc jobs in dublin county dublin

Sr Dir CMC Regulatory Affairs

Assistant Manager, Regulatory Affairs CMC (Global)

Director Regulatory Affairs Global CMC

Senior Manager, European Regulatory Policy and Intelligence

Director Regulatory CMC Sciences Project Management

Director Respiratory Regulatory CMC

Senior Manager, Regulatory Affairs CMC

Director, Regulatory Affairs Medical Devices & Combination Product

Digital CMC Consultant (Life Sciences)

Project Scheduler - CMC

CMC Lead, Launch Product, Small Molecules

Technical Project Manager -CMC

Associate Director, Global Sourcing - External Manufacturing

Director, CMC Drug Substance Manufacturing

Senior Technical Project Manager - CMC

Associate Director, Global Sourcing - External Manufacturing

Manager, External Manufacturing and Supply

Associate Director, External Manufacturing and Supply

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