Find Director regulatory Jobs in Dublin, D

Associate Director, Drug Product Development
Jazz Pharmaceuticals —Dublin, County Dublin
- €157,600–€236,400 a year
- Engineering
- Project management
- Leadership
- Annual leave
14d
Head of Library, Archives and Research Services
National Gallery of Ireland —Dublin, County Dublin
- €87,510–€98,508 a year
- Weekend availability
- English
- Research
- Project management
- Annual leave
Associate Director Inspection Management (GCP)
Regeneron —Dublin, County Dublin
- €101,500–€165,200 a year
- Management
- Supervising experience
- Presentation skills
- Annual leave
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
PGIM | Director, Designated Person For Fund Risk (PCF 39C)
PGIM —Dublin, County Dublin
- Full-time
- Python
- Annual leave
Head of Assessment and Audit
ComReg —North Wall, County Dublin
- €110,955.62 a year
- Full-time
- Hybrid work
- Master's degree
- Supervising experience
- No degree
- Annual leave
- Employee assistance program
Quick apply
Director of Spectrum and Market Framework
ComReg —North Wall, County Dublin
- €183,771.00–€183,771.62 a year
- Full-time
- Hybrid work
- Master's degree
- Continuous improvement
- Business
- Annual leave
- Employee assistance program
Quick apply
Customer Operations Manager
Blackhawk Network —Santry, County Dublin
- Full-time
- Hybrid work
- Analysis skills
- AI
- Leadership
- Annual leave
- Employee assistance program
Principal, Global Feasibility (pre-award strategy) - Sponsor-dedicated - EMEA
サイネオス・ヘルス —Dublin, County Dublin
- Doctoral degree
- Research
- Master's degree
Senior Director, Actuarial & Regulatory Affairs - Pricing & Underwriting
Optum —Dublin, County Dublin
- Full-time
- Bachelor's degree
- No degree
- AI
Executive Director, Worldwide Operations Office - Pharmacovigilance
Regeneron —Dublin, County Dublin
- €172,500–€288,300 a year
- Master's degree
- Bachelor's degree
- AI
- Annual leave
Director Amazon EMEA Energy & Water
Amazon Data Services Ireland Limited —Dublin, County Dublin
- Full-time
- Engineering
- AWS
- Analysis skills
Director, AI Compliance Governance Lead
Novartis —Dublin, County Dublin
- €102,200–€189,800 a year
- Full-time
- Hybrid work
- Doctoral degree
- English
- Master's degree
8d
PGIM | Director, Designated Person For Fund Risk
Prudential —Dublin, County Dublin
- Full-time
- Python
- Annual leave
Associate Director, Regulatory Affairs - Pricing & Underwriting
Optum —Dublin, County Dublin
- Full-time
- Master's degree
- Analysis skills
- Presentation skills
5d
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
AVP - Third Party Management / Outsourcing Specialist (m/f/d)
Sumitomo Mitsui Banking Corporation —Dublin, County Dublin
- €49,000–€91,000 a year
- Hybrid work
- English
- Bachelor's degree
- Business
- Annual leave
Legal Counsel Europe IB
PepsiCo —DUBLIN 2, County Dublin
- Remote
- English
- Project management
- Bachelor's degree
Senior Finance Manager
Logic Security Services Ltd —DUBLIN 12, County Dublin
- €50,000–€60,000 a year
- Full-time
- Hybrid work
- Management
- English
- Microsoft Office
Quick apply
14d
Director, European and UK Public Policy
Whatnot —Dublin, County Dublin
- €200,000–€276,000 a year
- Full-time
- Hybrid work
- Communication skills
- Work from home

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Associate Director, Drug Product Development

Jazz Pharmaceuticals -
Dublin, County Dublin

Apply Now

Job details

€157,600–€236,400 a year
14 days ago

Benefits

Annual leave

Qualifications

Engineering
Project management
Product development
Chemistry
Quality systems
Leadership
Communication skills

Full job description

Job Details

Req ID:

R011248

Locations:

Dublin, IE; London, London, City of, UK; California - [Remote/Home-Based]

Category:

Technical Operations

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

The Associate Director of Drug Product Development is responsible for providing scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs at various stages of the development life-cycle including preformulation, formulation and process development, technical transfer and validation. The Associate Director of Drug Product Development will oversee drug product aspects of development and manufacturing projects from pre-formulation and product feasibility through to clinical trial supply and technology transfer/commercialization. In addition, the Associate Director of Drug Product Development may provide leadership of cross-functional CMC development teams. The Associate Director of Drug Product Development will have broad experience in pharmaceutical product development, demonstrated problem solving ability, module 3 authorship, development of robust manufacturing processes through designed experiments and data analysis, and excellent project management, teamwork and leadership skills.

Essential Functions

Leads the development of small molecule drug product formulations, appropriate to the phase of pharmaceutical development, with sufficient stability and robustness for clinical and/or commercial manufacturing.
Responsible for specifying product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, required analytical methodology, packaging (clinical and commercial); and in developing robust processes for pharmaceutical production.
Directs projects and leads cross-functional teams (as required) with technical proficiency, scientific creativity, collaboration with others to achieve project goals on time and within budget.
Create intellectual property covering Jazz Pharmaceuticals products and ensure freedom to operate in the development of new drug products
Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).
Direct technical projects (internally and at CDMOs) including developing detailed technical work plans and managing performance of vendors.
Work cooperatively with, or lead, internal and external teams as required.
Author CMC sections of regulatory dossiers for products at all stages to enable acceptance by global regulators.
Supports asset due diligence and new product introduction and integrations
current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.

Required Knowledge, Skills, and Abilities

>10 years’ experience in drug product development in the pharmaceutical industry required. Direct experience with formulation development, process development, technical transfer and/or process validation.
Demonstrated technical proficiency, engineering, collaboration with others, and independent thought. Strong teamwork skills.
Demonstrated troubleshooting and problem-solving skills including the use of designed experiments, statistical process control,
Development/authorship of CMC regulatory filings for pharmaceutical products.
Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms preferred.
Excellent written and verbal communication skills
Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
Experience in intellectual property development desirable.
Proven project management skills for technical programs.
Flexibility to travel on company business when required

Required/Preferred Education and Licenses

Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work-related experience required.

Description of Physical Demands

Occasional mobility within office environment. Routinely sitting for extended periods of time.
Constantly operating a computer, printer, telephone and other similar office machinery.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $157,600.00 - $236,400.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings : https://careers.jazzpharma.com/benefits.html.

Apply Now

Refine Your Search

director regulatory jobs in dublin, d

Associate Director, Drug Product Development

Head of Library, Archives and Research Services

Associate Director Inspection Management (GCP)

Executive Director, Global Patient Safety Sciences Delivery

PGIM | Director, Designated Person For Fund Risk (PCF 39C)

Head of Assessment and Audit

Director of Spectrum and Market Framework

Customer Operations Manager

Principal, Global Feasibility (pre-award strategy) - Sponsor-dedicated - EMEA

Senior Director, Actuarial & Regulatory Affairs - Pricing & Underwriting

Executive Director, Worldwide Operations Office - Pharmacovigilance

Director Amazon EMEA Energy & Water

Director, AI Compliance Governance Lead

PGIM | Director, Designated Person For Fund Risk

Associate Director, Regulatory Affairs - Pricing & Underwriting

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

AVP - Third Party Management / Outsourcing Specialist (m/f/d)

Legal Counsel Europe IB

Senior Finance Manager

Director, European and UK Public Policy

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