Find 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
Tax Resolutions Senior Associate / Assistant Manager / Manager
CBTax —Dublin, County Dublin
- Analysis skills
- No degree
- Communication skills
Quick apply
Senior Surveyor
Cushman & Wakefield —DUBLIN 2, County Dublin
- Full-time
- English
- Microsoft Office
- Business development
Quick apply
Global Partner Manager - Salesforce Ecosystem
MaxAccelerate —Dublin, County Dublin
- Full-time
- Remote
- Salesforce
Quick apply
Graduate Construction Consultancy Project Manager (Dublin)
Mitchell McDermott —Dublin, County Dublin
- Full-time
- Computer skills
- In-person
- Construction Management
Quick apply
8d
Tax Manager
Russell Brennan Keane —Dublin, County Dublin
- Business development
- Communication skills
- Employee assistance program
Commercial Manager - Rail
AtkinsRéalis —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Office
Assistant Tax Manager
CBTax —Dublin, County Dublin
Quick apply
11d
Transportation Engineer
DBFL Consulting Engineers —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Master's degree
- Analysis skills
- Annual leave
Quick apply
Senior fire safety engineer
Marker Group —Dublin, County Dublin
- €60,000–€85,000 a year
- Full-time
- Engineering
- Master's degree
- Analysis skills
Quick apply
8d
Senior Area Manager, Ireland - Tommy Hilfiger & Calvin Klein
Tommy Hilfiger —Dublin, County Dublin
- Full-time
Head of Design - Decarbonisation
Alternative Heat —Santry, County Dublin
- Full-time
- No degree
Quick apply
Senior / Principal Civil Engineer
Civic —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Word
- AutoCAD
- Microsoft Excel
- Annual leave
- Employee assistance program
Quick apply
Senior Associate - MLRO
Waystone —Dublin, County Dublin
- Full-time
- Hybrid work
- Presentation skills
- No degree
- Communication skills
Quick apply
Associate - Corporate Secretarial Services (COE)
Waystone —Dublin, County Dublin
- Full-time
- Hybrid work
- English
- Bachelor's degree
- No degree
Quick apply
Associate Director - Pharmacy Contract Strategy & Negotiation
Optum —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Bachelor's degree
- No degree
5h

More jobs to discover

Find similar jobs that you might be interested in.

Tax Resolutions Senior Associate / Assistant Manager / Manager
CBTax —Dublin, County Dublin
In this role, you will respond to HMRC/Revenue enquiries, draft high-quality responses, engage directly with company directors and technical specialists, handle…
Quick apply

I want to receive the latest job alerts for 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

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

Contract Negotiator jobs in Dublin, County Dublin

Commercial Manager jobs in Dublin, County Dublin

Director Of Regulatory Affairs jobs in Dublin, County Dublin

Engineer jobs in Dublin, County Dublin

Tax Manager jobs in Dublin, County Dublin

Secretary jobs in Dublin, County Dublin

Senior Tax Associate jobs in Dublin, County Dublin

Senior Civil Engineer jobs in Dublin, County Dublin

5 Month Contract jobs in Dublin, County Dublin

Senior Contract Specialist jobs in Dublin, County Dublin

Contract jobs in Cavan, County Cavan

Construction Project Manager jobs in County Wexford

Construction Project Manager jobs in Limerick, County Limerick

Construction Project Manager jobs in Monroe, County Galway

Logistics Manager jobs in Dublin, County Dublin

Construction Project Manager jobs in Cork, County Cork

Disability Manager Hse jobs in Dublin, County Dublin

Commercial Manager jobs in County Dublin

General Manager jobs in Cork, County Cork

Chemical Regulatory jobs in Dublin, County Dublin

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

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

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Tax Resolutions Senior Associate / Assistant Manager / Manager

Senior Surveyor

Global Partner Manager - Salesforce Ecosystem

Graduate Construction Consultancy Project Manager (Dublin)

Tax Manager

Commercial Manager - Rail

Assistant Tax Manager

Transportation Engineer

Senior fire safety engineer

Senior Area Manager, Ireland - Tommy Hilfiger & Calvin Klein

Head of Design - Decarbonisation

Senior / Principal Civil Engineer

Senior Associate - MLRO

Associate - Corporate Secretarial Services (COE)

Associate Director - Pharmacy Contract Strategy & Negotiation

More jobs to discover

I want to receive the latest job alerts for 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