Find The associate director, linux/unix admin Jobs in Blackrock, D

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Bachelor's degree
- No degree
- In-person
- Annual leave
Associate Director, Supply Chain Business Support (Remote / Home Based)
Jazz Pharmaceuticals —Dublin, County Dublin
- Engineering
- Business
- Communication skills
- Annual leave
Senior Producer
Virtuos Games —Dublin, County Dublin
- Full-time
- English
- Analysis skills
- Project management
- Sick pay
ERP Project Director
PM Group —Dublin, County Dublin
- Oracle
- Computer Science
- ERP systems
Senior Area Manager, Ireland - Tommy Hilfiger & Calvin Klein
Tommy Hilfiger —Dublin, County Dublin
- Full-time
R&D Technical Consultant
CBTax —Dublin, County Dublin
- Analysis skills
- In-person
Quick apply
Global Financial Crimes Manager
Bank of America —Dublin, County Dublin
- Full-time
- Bachelor's degree
- Employee assistance program
Compliance Support Executive
Russell Investments —Dublin, County Dublin
- Full-time
- In-person
- Business
- Communication skills
Governance, Risk & Frameworks Analyst - Dublin
CRH Group Services Ltd. —Dublin, County Dublin
- Full-time
- Analysis skills
- Driving
- In-person
Quick apply
Associate Construction Director - Infrastructure, Civil and Build
Mace —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Outlook
- Project management
- Construction experience
12d
Global Labelling Associate Director, Content (Established Products)
Novartis —Dublin, County Dublin
- €75,880–€140,920 a year
- Full-time
- Hybrid work
- Continuous improvement
6d
Associate Director – Global Statutory Audit
Grant Thornton —Dublin, County Dublin
- Full-time
- Continuous improvement
- Communication skills
Associate Director, R&D Project Finance
Jazz Pharmaceuticals —Dublin, County Dublin
- Microsoft Excel
- Oracle
- Finance
- Annual leave
3d
Associate Director (Water)
AtkinsRéalis —Dublin, County Dublin
- Full-time
- Hybrid work
- Leadership
Senior Associate Director Transport Planner (Dublin / Cork / Belfast)
Jacobs —Dublin, County Dublin
- Hybrid work
- Business development
- Mentoring
- Leadership
- Annual leave
Associate Director / Manager Insurance Risk and Actuarial
Grant Thornton —Dublin, County Dublin
- Full-time
- Analysis skills
- Mentoring
- Life insurance
MS&T Raw Materials and Validation Lead – Associate Director - Dunboyne
MSD —Dunboyne, County Meath
- Full-time
- Hybrid work
- Engineering
- Continuous improvement
- Cleaning
3d
Senior Associate, IT, Network Engineer (Fixed Term Contract - 12 Month)
MUFG Investor Services —Dublin, County Dublin
- Full-time
- Azure
- Computer Science
- AWS
Quick apply
Associate Director, Reporting & Insights Partner R&D & Technical Operations
Jazz Pharmaceuticals —Dublin, County Dublin
- Oracle
- Master's degree
- Analysis skills
- Annual leave
3d
Senior Associate (Corporate Governance & Company Secretarial)
PwC —Dublin, County Dublin
- Full-time
- Recruiting
- Organisational skills
- Communication skills

I want to receive the latest job alerts for the associate director, linux/unix admin in blackrock, d

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

the associate director, linux/unix admin jobs near blackrock, d

Associate Director jobs in Dublin, County Dublin

R&D Engineer jobs in Dublin, County Dublin

Delivery Manager jobs in Dublin, County Dublin

Risk Analyst jobs in Dublin, County Dublin

Finance Manager jobs in Dublin, County Dublin

Senior Network Engineer jobs in Dublin, County Dublin

Senior Producer jobs in Dublin, County Dublin

Transport Planner jobs in Dublin, County Dublin

Governance Officer jobs in Dublin, County Dublin

Data Director jobs in Dublin, County Dublin

Director Of Technology jobs in Dublin, County Dublin

Associate Director jobs in County Louth

Associate Director jobs in County Dublin

Associate Director jobs in Limerick, County Limerick

Director Of Service jobs in Dublin, County Dublin

R&d Engineer jobs in Limerick, County Limerick

R&d Engineer jobs in Annacarriga, County Clare

R&d Engineer jobs in County Dublin

Electronics Engineer jobs in County Cork

Management jobs in Cork, County Cork

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Regeneron -
Dublin, County Dublin

Apply Now

Job details

€101,500–€165,200 a year

Benefits

Annual leave

Qualifications

Bachelor's degree

Full job description

Build our future together:

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions.

Where and when:

This is a Dublin, Ireland based position and would you to be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. If eligible, we can offer relocation benefits.

Discover your role:

Lead product development activities from a CMC regulatory standpoint with input from senior management.

Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities.

Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.

Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.

Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).

Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents;

Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks.

Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.

Identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency.

Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.

• Find opportunities to initiate operational changes and policy modifications.• Manage and coach team member(s).

This role requires:

To be considered a bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience. An advanced degree is preferred.
Proven track record supporting biological products through development and approval is a distinct advantage.
It is required to have a good understanding of current CMC worldwide regulations and guidelines.
Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products is a plus.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€101,500.00 - €165,200.00

Apply Now

Refine Your Search

the associate director, linux/unix admin jobs in blackrock, d

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

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

Senior Producer

ERP Project Director

Senior Area Manager, Ireland - Tommy Hilfiger & Calvin Klein

R&D Technical Consultant

Global Financial Crimes Manager

Compliance Support Executive

Governance, Risk & Frameworks Analyst - Dublin

Associate Construction Director - Infrastructure, Civil and Build

Global Labelling Associate Director, Content (Established Products)

Associate Director – Global Statutory Audit

Associate Director, R&D Project Finance

Associate Director (Water)

Senior Associate Director Transport Planner (Dublin / Cork / Belfast)

Associate Director / Manager Insurance Risk and Actuarial

MS&T Raw Materials and Validation Lead – Associate Director - Dunboyne

Senior Associate, IT, Network Engineer (Fixed Term Contract - 12 Month)

Associate Director, Reporting & Insights Partner R&D & Technical Operations

Senior Associate (Corporate Governance & Company Secretarial)

I want to receive the latest job alerts for the associate director, linux/unix admin in blackrock, d

Related Searches

Explore jobs in more locations

Build our future together:

Discover your role:

Jobseeker tools

Employer Tools

Browse

Stay Connected