Find Territory manager Jobs in Dublin 2, D

Manager, Regulatory Affairs
Azurity Pharmaceuticals - Ireland —Dublin, County Dublin
- English
- Bachelor's degree
- Communication skills
Global Program Manager
Avnet —Dublin, County Dublin
- Full-time
- Sales
- Project management
- Bachelor's degree
Relationship Manager, Scale
Intercom —Dublin, County Dublin
- Hybrid work
- Business
- Annual leave
- Work from home
Business Development Manager
DSV —Dublin, County Dublin
- Full-time
- Management
- Sales
- Business development
- Annual leave
Office Manager
iCIMS Talent Acquisition —DUBLIN 2, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
- Sick pay
Sales Leader, BDR Manager France- French Speaking
Salesforce —Dublin, County Dublin
- Full-time
- Sales
- English
- Leadership
Area Manager, Urology
M.E.D Surgical Limited IRL —Dublin, County Dublin
- Full-time
- Sales
- Marketing
Quick apply
Manager, Product Experience & Design
Mastercard —Dublin, County Dublin
- Full-time
- Master's degree
- AI
2d
Senior Affera Therapy Specialist
Medtronic —Dublin, County Dublin
- €63,280–€94,920 a year
- Full-time
- Sales
- Bachelor's degree
- Recruiting
9d
Clinical Specialist Coronary
Abbott Laboratories —Dublin, County Dublin
- Full-time
- Microsoft Office
- Bachelor's degree
- IT
Office Manager
iCims —DUBLIN 2, County Dublin
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
- Sick pay
Account Manager Dublin
HILTI —Dublin, County Dublin
- Sales
- In-person
- Communication skills
- Fuel card
7d
Revenue Operations Manager, EMEA
Okta —Dublin, County Dublin
- €68,000–€93,500 a year
- Sales
- Continuous improvement
- Communication skills
- Annual leave
Business Development Manager
Ard Ri Marble Ltd —Dublin, County Dublin
- From €55,000 a year
- Full-time
- Microsoft Powerpoint
- Sales
- No degree
- Store discount
- Employee assistance program
Quick apply
1d
Major Account Manager - Private Sector
Palo Alto Networks —Dublin, County Dublin
- Sales
Principal Commercial Sales Enablement Partner, EMEA
Klaviyo —Dublin, County Dublin
- €88,000–€132,000 a year
- Sales
- Leadership
- Communication skills
Quick apply
Territory Manager in Training -Life Science
Ecolab Inc. —Dublin, County Dublin
- Full-time
- Customer service
- English
- Microsoft Office
- Life insurance
Account Executive
Zendesk —Dublin, County Dublin
- €111,000–€167,000 a year
- Full-time
- Sales
- Research
- Bachelor's degree
Sales Account Manager
IQVIA —Dublin, County Dublin
3d
Channel Partner Manager
Assay Genie —Dublin, County Dublin
- €45,000–€65,000 a year
- Full-time
- Remote
- Management
- Recruiting
- Leadership
3d

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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

territory manager jobs in dublin 2, d

Manager, Regulatory Affairs

Global Program Manager

Relationship Manager, Scale

Business Development Manager

Office Manager

Sales Leader, BDR Manager France- French Speaking

Area Manager, Urology

Manager, Product Experience & Design

Senior Affera Therapy Specialist

Clinical Specialist Coronary

Office Manager

Account Manager Dublin

Revenue Operations Manager, EMEA

Business Development Manager

Major Account Manager - Private Sector

Principal Commercial Sales Enablement Partner, EMEA

Territory Manager in Training -Life Science

Account Executive

Sales Account Manager

Channel Partner Manager

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