Find Director pharmaceutical Jobs in Dublin, 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
1d
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
Project Director - Life Sciences
Jacobs —Dublin, County Dublin
- Hybrid work
- Management
- Engineering
- Project management
1d
Associate Director, Pharmacology
Grifols Worldwide Op Ltd —Dublin, County Dublin
- Full-time
- Doctoral degree
Associate Director, Pharmacy Contract Strategy & Negotiations
Optum —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Bachelor's degree
- Leadership
4d
Director, Government Affairs Europe
Regeneron —Dublin, County Dublin
- €119,900–€200,400 a year
- Spanish
- English
- Bachelor's degree
- Annual leave
Pathology Project Manager
ICON Plc —Dublin, County Dublin
- Full-time
- Project management
- Bachelor's degree
- No degree
Commercial Affairs Director (12 month FTC)
Inizio —Dublin, County Dublin
- Hybrid work
- Bachelor's degree
- No degree
- Communication skills
11d
Director, Clinical Development
Gilead Sciences —Dublin, County Dublin
- Full-time
- Doctoral degree
- Research
- Analysis skills
Executive Director, Global Patient Safety Sciences Delivery
Regeneron —Dublin, County Dublin
- €172,500–€288,300 a year
- Doctoral degree
- Master's degree
- Business
- Annual leave
2d
Quality Control Specialist
Jazz Pharmaceuticals —Dublin, County Dublin
- Master's degree
- Bachelor's degree
- No degree
- Annual leave
4d
Programme Director MSc in Procurement and Supply Chain Management
Griffith College —DUBLIN 8, County Dublin
- Full-time
- Management
- Doctoral degree
- Master's degree
- Free parking
- Work from home
Quick apply
Director, Medical Society Partnerships & Congresses
Novartis —Dublin, County Dublin
- Full-time
- Doctoral degree
- Communication skills
9d
Associate Director, Network Contracting
Optum —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Associate Director Inspection Management (GCP)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Management
- Supervising experience
- Presentation skills
- Annual leave
2d
Clinical Development Director - Renal
Novartis —Dublin, County Dublin
- Full-time
- Doctoral degree
- Writing skills
- No degree
Clinical Project Management Director (Indication Director)
IQVIA —Dublin, County Dublin
- Full-time
- Bachelor's degree
- Continuous improvement
- No degree
2d
DBSO Director, Lean
Danaher Corporation —Dublin, County Dublin
- Full-time
- Remote
- Engineering
- Project management
- Bachelor's degree
Operations Director
MTM Engineering —Dublin, County Dublin
- Full-time
- Bachelor's degree
- No degree
- Communication skills
Quick apply
Quality Director Group Global Quality
Uniphar PLC —DUBLIN 24, County Dublin
- Full-time
- Engineering
- English
- Master's degree
Quick apply

I want to receive the latest job alerts for director pharmaceutical in dublin, 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

director pharmaceutical jobs near dublin, d

Development Director jobs in Dublin, County Dublin

Associate Director jobs in Dublin, County Dublin

Commercial Director jobs in Dublin, County Dublin

Clinical Director jobs in Dublin, County Dublin

Medical Director jobs in Dublin, County Dublin

Contract Negotiator jobs in Dublin, County Dublin

Director jobs in Dublin, County Dublin

Director Engineering jobs in Dublin, County Dublin

Product Director jobs in Dublin, County Dublin

Associate Director jobs in County Dublin

Sales Director jobs in Cork, County Cork

Associate Director jobs in County Louth

Director Nursing In Hse jobs in County Dublin

Theatre, Assistant Director jobs in Dublin, County Dublin

Trust Safety Manager jobs in Dublin, County Dublin

Director Nursing jobs in Dublin, County Dublin

Associate Director jobs in Cork, County Cork

Qa Director jobs in Dublin, County Dublin

Associate Director jobs in Limerick, County Limerick

Physician Associate jobs in Dublin 15, County Dublin

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Regeneron -
Dublin, County Dublin

Apply Now

Job details

€101,500–€165,200 a year
1 day ago

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

director pharmaceutical jobs in dublin, d

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Director, Regulatory Affairs Medical Devices & Combination Product

Project Director - Life Sciences

Associate Director, Pharmacology

Associate Director, Pharmacy Contract Strategy & Negotiations

Director, Government Affairs Europe

Pathology Project Manager

Commercial Affairs Director (12 month FTC)

Director, Clinical Development

Executive Director, Global Patient Safety Sciences Delivery

Quality Control Specialist

Programme Director MSc in Procurement and Supply Chain Management

Director, Medical Society Partnerships & Congresses

Associate Director, Network Contracting

Associate Director Inspection Management (GCP)

Clinical Development Director - Renal

Clinical Project Management Director (Indication Director)

DBSO Director, Lean

Operations Director

Quality Director Group Global Quality

I want to receive the latest job alerts for director pharmaceutical in dublin, d

Related Searches

Explore jobs in more locations

Build our future together:

Discover your role:

Jobseeker tools

Employer Tools

Browse

Stay Connected