Find Territory manager Jobs in Dublin 15, D

Manager, Regulatory Affairs
Azurity Pharmaceuticals - Ireland —Dublin, County Dublin
- English
- Bachelor's degree
- Communication skills
Ireland PepsiCo Beverages Senior Manager
PepsiCo —DUBLIN 2, County Dublin
- Sales
- Analysis skills
- Leadership
Implementation Manager
Primark —Dublin, County Dublin
- Every weekend
- IT
1h
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
Business Development Executive
IRISH DISTILLERS LTD —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Sales
- Salesforce
- Annual leave
Quick apply
Relationship Manager, Scale
Intercom —Dublin, County Dublin
- Hybrid work
- Business
- Annual leave
- Work from home
Senior Affera Therapy Specialist
Medtronic —Dublin, County Dublin
- €63,280–€94,920 a year
- Full-time
- Sales
- Bachelor's degree
- Recruiting
8d
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
15h
Manager, Product Experience & Design
Mastercard —Dublin, County Dublin
- Full-time
- Master's degree
- AI
1d
Territory Sales Manager
Sherwin-Williams —Dublin, County Dublin
- €45,000–€48,000 a year
- Full-time
- Sales
- Salesforce
- Negotiation
- Fuel card
- Annual leave
1d
Senior Renewals Manager
Salesforce —Dublin, County Dublin
- Full-time
- Spanish
- Salesforce
- English
1d
Sales Account Manager
IQVIA —Dublin, County Dublin
2d
Senior Business Development Manager - Vodafone Business
CPM Ireland —Dublin, County Dublin
- €32,000–€60,000 a year
- Full-time
- Microsoft Excel
- Sales
- Analysis skills
- Fuel card
- Annual leave
Quick apply
2d
Channel Partner Manager
Assay Genie —Dublin, County Dublin
- €45,000–€65,000 a year
- Full-time
- Remote
- Management
- Recruiting
- Leadership
2d
Sales Development Strategy and Operations Manager
Okta —Dublin, County Dublin
- €78,000–€108,000 a year
- Sales
- Presentation skills
- AI
- Annual leave
2d
Digital Sales Manager - Technology Sales, German Speaking
Microsoft —Dublin, County Dublin
- €78,600–€146,400 a year
- Full-time
- Sales
- Marketing
- Bachelor's degree
5d
Senior Field Sales Representative - National Broadband Ireland
CPM Ireland —Dublin, County Dublin
- €32,000–€57,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- IT
- Fuel card
Quick apply
5d
Area Sales Manager
ghd Hair —Dublin, County Dublin
- Full-time
- Doctoral degree
- Sales
- Social media management
5d
Account Manager Dublin
HILTI —Dublin, County Dublin
- Sales
- In-person
- Communication skills
- Fuel card
6d

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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

Apply Now

Refine Your Search

territory manager jobs in dublin 15, d

Manager, Regulatory Affairs

Ireland PepsiCo Beverages Senior Manager

Implementation Manager

Business Development Manager

Office Manager

Business Development Executive

Relationship Manager, Scale

Senior Affera Therapy Specialist

Business Development Manager

Manager, Product Experience & Design

Territory Sales Manager

Senior Renewals Manager

Sales Account Manager

Senior Business Development Manager - Vodafone Business

Channel Partner Manager

Sales Development Strategy and Operations Manager

Digital Sales Manager - Technology Sales, German Speaking

Senior Field Sales Representative - National Broadband Ireland

Area Sales Manager

Account Manager Dublin

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