Find pharmaceutical quality control Jobs in dublin, d

Manager, Regulatory Affairs
Azurity Pharmaceuticals - US —Dublin, County Dublin
- English
- Bachelor's degree
- Communication skills
Jr Assoc, Accounting
West Pharmaceutical Services —Dublin, County Dublin
- Microsoft Office
- Bachelor's degree
- Accounting
10d
Project Scheduler - CMC
Sia —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Project management
- Bachelor's degree
Quick apply
General Operative (Mechanical)
Capital Switchgear —Rathcoole, County Dublin
- €17–€21 an hour
- Weekend availability
- No experience needed
- English
- Assembly
- Free parking
- Employee assistance program
Quick apply
HR Business partner
Grifols Worldwide Op Ltd —Dublin, County Dublin
- Full-time
- Hybrid work
- Spanish
- Bachelor's degree
- Human resources
Basic Grade Pharmacist - temporary
Tallaght University Hospital —Tallaght, County Dublin
- Full-time
- No degree
- Annual leave
- Sick pay
13d
Principal Clinical Data Science Lead
ICON Plc —Dublin, County Dublin
- Full-time
- Oracle
- Microsoft Office
- Project management
5d
Quality Director Group Global Quality
Uniphar PLC —DUBLIN 24, County Dublin
- Full-time
- Engineering
- English
- Master's degree
Quick apply
10d
QAQC Engineer
Winthrop Technologies —Dublin, County Dublin
- Full-time
- Engineering
- Bachelor's degree
- Organisational skills
Quick apply
Technical Writer
CEL - Critical Power —Dublin, County Dublin
- Full-time
- Continuous improvement
- Organisational skills
- Manufacturing
Quick apply
Director Respiratory Regulatory CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
- Manufacturing
Turnover Manager
Fohntech Group —DUBLIN 15, County Dublin
- Full-time
- No degree
- Construction
10d
Lead Process Engineer
DPS Group —Dublin, County Dublin
- English
- Microsoft Office
- Leadership
Global Lead Auditor
Uniphar PLC —DUBLIN 24, County Dublin
- Full-time
- Leadership
- Communication skills
Quick apply
Director Regulatory CMC Sciences Project Management
Viatris —Northern Cross, County Dublin
- Full-time
- Microsoft Office
- Project management
- Mentoring
Validation Engineer
CAI —Dublin, County Dublin
- Full-time
- Engineering
- Bachelor's degree
- Communication skills
Quick apply
Advanced Specialist Pharmacist - Oncology, Haematology and Aseptic Compounding
Beaumont Hospital —Dublin, County Dublin
- €82,756–€94,871 a year
- Full-time
- Management
- Research
- Master's degree
10d
Test Pack Manager
Fohntech Group —DUBLIN 15, County Dublin
- Full-time
- Bachelor's degree
Geo-Environmental Consultant
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Bachelor's degree
- Communication skills
Director, Combination Product Development
Viatris —Northern Cross, County Dublin
- Full-time
- Engineering
- Organisational skills
- Leadership

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Manager, Regulatory Affairs

Azurity Pharmaceuticals - US
Dublin, County Dublin

Apply Now

Job details

Qualifications

Biology
English
Bachelor's degree
Communication skills
Marketing

Full job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

Manager, Regulatory Affairs: Managing EU and International Regulatory activities for assigned projects

Manage the regulatory filings of medicinal products via EU centralized procedure as well as MRP/DCP/NP procedures, including but not limited to MAAs, variations, MATs, and other associated life cycle maintenances submissions. Main role is to be a primary interface with the EMA and maintaining good working relationship with Product Leads, Rapporteurs, CHMP members and other EMA officials to secure timely approval of filings. Support in International territories in Life cycle maintenance.

Principle Responsibilities:

Manage and coordinate regulatory submissions for all projects to include but not limited to Scientific Advice, Pediatric Implementation Plan submissions, MAAs, variations and other associated life cycle maintenances submissions.
Develop and implement regulatory strategies for product registration and life cycle
Lead cross-functional discussions to align on submission strategies, prioritize activities, and establish realistic implementation timelines for regulatory activities based on the cross-functional requirements.
Review labelling (SPC, PIL and Labelling) to ensure compliance against current guidelines and standards
Review change controls for the regulatory team
Ownership of all outside communication with EU/EEA Health Authorities (EMA, National
Competent Authorities) on behalf of the Company
Provide guidance to support with regulatory related questions and complaints
Monitor evolving regulatory requirements and provide proactive advice to cross functional teams
Follow company policies and procedures
Contribute to generate and review SOPs and Work instructions
Periodically reviewing the product information (SPC, PIL and Labelling) for compliance against the Core Safety Information (CSI) as well as current EU guidelines and standards
Manage the artwork preparation and approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs, or changes to existing packaging
Managing publishing and translation activities with support from partner CRO
Support review of EU promotional material

Qualifications and Education Requirements

Bachelor of Science, Biological Sciences or other related area of study
5-7+ years of experience in Regulatory Affairs especially with European, UK exposure
Regulatory Affairs exposure to China would be considered a plus
Proven experience with EMA, NCA’s
Strong background in pre-marketing activities and preparation of MAA’s
Ability to perform under pressure with limited resources
Excellent communication and presentation skills in English
Strong writing analytical and problem-solving abilities

#LI-Hybrid

Apply Now

Refine Your Search

pharmaceutical quality control jobs in dublin, d

Manager, Regulatory Affairs

Jr Assoc, Accounting

Project Scheduler - CMC

General Operative (Mechanical)

HR Business partner

Basic Grade Pharmacist - temporary

Principal Clinical Data Science Lead

Quality Director Group Global Quality

QAQC Engineer

Technical Writer

Director Respiratory Regulatory CMC

Turnover Manager

Lead Process Engineer

Global Lead Auditor

Director Regulatory CMC Sciences Project Management

Validation Engineer

Advanced Specialist Pharmacist - Oncology, Haematology and Aseptic Compounding

Test Pack Manager

Geo-Environmental Consultant

Director, Combination Product Development

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