Find pharmaceutical quality control Jobs in dublin county dublin

Manager, Regulatory Affairs
Azurity Pharmaceuticals - Ireland —Dublin, County Dublin
- English
- Bachelor's degree
- Communication skills
Document Control Manager
DPS Group —Citywest, County Dublin
- Monday to Friday
- Microsoft Excel
- Management
- Customer service
Manager, Regulatory Affairs
Azurity Pharmaceuticals - US —Dublin, County Dublin
- English
- Bachelor's degree
- Communication skills
QA Manager & Qualified Person (QP)
RxSource —Dublin, County Dublin
- Engineering
- Bachelor's degree
- No degree
Turnover Manager
Fohntech Group —DUBLIN 15, County Dublin
- Full-time
- No degree
- Construction
6d
Quality Engineering Manager
Embecta —Dún Laoghaire, County Dublin
- Full-time
- Engineering
- Communication skills
Quality Manager, Global Distribution Quality
Amgen —Dublin, County Dublin
- Doctoral degree
- Master's degree
- Bachelor's degree
Operations Technician
Charles River Laboratories —Dublin, County Dublin
- Full-time
- Sales
- Microsoft Office
- No degree
- Annual leave
8d
GMDP Quality Assurance Manager
WEP Clinical —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Director Regulatory Affairs Global CMC
Viatris —Northern Cross, County Dublin
- Full-time
- Project management
- Mentoring
- Manufacturing
Microbiologist - 12 Month FTC
Embecta —Dún Laoghaire, County Dublin
- Full-time
- Microsoft Office
- Analysis skills
- Manufacturing
Test Pack Manager
Fohntech Group —DUBLIN 15, County Dublin
- Full-time
- Bachelor's degree
Process Engineer ( 12 Months Agency Contract )
Viatris —Damastown, County Dublin
- Full-time
- Engineering
- Bachelor's degree
- Manufacturing
Geo-Environmental Consultant
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Bachelor's degree
- Communication skills
Senior Project Engineer (QC Lab Equipment) / West Dublin / Biopharma
PM Group —Dublin, County Dublin
- Engineering
- Project management
- Quality control
Sr. Manager, Medical Writing
Alfasigma Group —Dublin, County Dublin
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
14d
Business Development and Pre-sales SME
Tata Consultancy Services —Dublin, County Dublin
- Call to connect
- Sales
- Business development
- Manufacturing
Basic Grade Pharmacist
Beaumont Hospital —Dublin, County Dublin
- €49,985–€78,433 a year
- Weekend availability
5d
Territory Manager in Training -Life Science
Ecolab Inc. —Dublin, County Dublin
- Full-time
- Customer service
- English
- Microsoft Office
- Life insurance
8d
Warehouse Operator
Charles River Laboratories —Dublin, County Dublin
- Full-time
- Leaving certificate
- No degree
- Organisational skills
- Annual leave
- Employee discount

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Manager, Regulatory Affairs

Azurity Pharmaceuticals - Ireland
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

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Refine Your Search

pharmaceutical quality control jobs in dublin county dublin

Manager, Regulatory Affairs

Document Control Manager

Manager, Regulatory Affairs

QA Manager & Qualified Person (QP)

Turnover Manager

Quality Engineering Manager

Quality Manager, Global Distribution Quality

Operations Technician

GMDP Quality Assurance Manager

Director Regulatory Affairs Global CMC

Microbiologist - 12 Month FTC

Test Pack Manager

Process Engineer ( 12 Months Agency Contract )

Geo-Environmental Consultant

Senior Project Engineer (QC Lab Equipment) / West Dublin / Biopharma

Sr. Manager, Medical Writing

Business Development and Pre-sales SME

Basic Grade Pharmacist

Territory Manager in Training -Life Science

Warehouse Operator

I want to receive the latest job alerts for pharmaceutical quality control in dublin county dublin

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