▷ [Urgent Search] Snr. Global Program Regulatory Manager

1 day ago


Dublin, Ireland Healthcare Businesswomen’s Association Full time

Job Description Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.

To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

Apply today and welcome to where we thrive together

This role offers hybrid working, requiring 3 days a week / 12 days a month based in office.

Job Description

As Senior Global Program Regulatory Manager, you will work with limited supervision to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). You may act as the RA program lead on programs of limited complexity.

The Senior Global Program Regulatory Manager is also a member of the RA sub team and may lead or represent RA in regional or cross functional teams. You may also act as a subject matter expert and/or assume a mentoring role.

Major Accountabilities:

Regulatory Strategy

- Provide input to global program regulatory strategy, including regulatory designations & innovative approaches and may provide global RA leadership for specific part of the program or act as lead for a program of limited complexity.
- Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables.
- Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for HA interactions. May lead or serve in HA meetings or local HA liaison respectively.

Regulatory Submissions

- Leads planning, preparation and submission of clinic trails, and the implementation of defined global registration strategy into regional submissions worldwide with country organizations.
- Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned.
- Lead regulatory activities during HA reviews, responding to questions and HA interactions.

Regulatory Excellence & Compliance

- Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.
- May serve as a RA subject matter expert and assume a mentoring role.

Life Cycle Management

- You may also focus on one of the following key areas of activity:

- Maintenance – preparation of selected global regulatory submissions.
- Portfolio Transformation – e.g. streamlining activities, divestment/ integration, portfolio transformation and manufacturing transfer.
- Business & Operational Excellence – collating, for example, registration samples, CPPs etc. to support submissions.

NB: if the Senior Global Program Regulatory Manager acts as a Team Lead, manage several direct reports.

Your Experience:

- Science based bachelors or advanced degree, plus advance understanding of pharmaceutical development, clinical trails.
- Awareness of post marketing/ brand optimization strategy, with track record of involvement in regulatory or pharmaceutical development in Phases I – IV, in multiple geographies.
- Strong interpersonal skills and experience working in a complex, cross functional organization and leading cross function teams.
- Compliance and Quality mindset.
- Fluency in English.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.

Skills Desired:

- Clinical Trials
- Cross-Functional Teams
- Detail-Oriented
- Drug Development
- Lifesciences
- Negotiation Skills
- Problem Solving Skills
- Regulatory Compliance
- Risk Management

#J-18808-Ljbffr


  • Audit Manager

    1 week ago


    Dublin, Ireland Verde Search Full time

    Role | Audit Manager Company | Globally recognised Accounting Firm Size | 300 across Ireland, 200+ in Dublin Focus| Leisure / Tech / Retail / Manufacturing sectors Tech | CaseWare Based | South Central Dublin Hybrid | 2-3 days a week in-office Offer | Attractive base salary + Bonus + Pension + Health + Partner Path Verde Search are partnering with a growing...


  • Dublin, Ireland Design Build Search Full time

    Design Build Search are working with a leading mechanical engineering contractor operating across Ireland. They are currently recruiting for a Contracts Manager to join our team and provide leadership and direction on all projects managed. Responsibilities: Responsible for driving operations and budget through successful leadership, organisation plans,...


  • Dublin, Ireland Guidant Global Full time

    Program Manager Contract role - 6 months, extendable Rate = DOE daily rate Location: UK based or Ireland based candidates only. Hybrid working environment. NO SPONSORSHIP provided, so You MUST hold UK citizenship OR EU/EEA citizenship or hold existing full rights to work in Ireland or UK. Programme Manager required for Advisory & Engagement Division of a...


  • Dublin, Ireland Verde Search Full time

    Role| Tax Assistant Manager Company| Highly respected specialist Irish Tax firm Size| 45 staff in Dublin (and growing) Areas| High profile business leaders, HNWI and their associated companies Based| Dublin 4 Hybrid| 2-3 days a week in-office Offer| €60k - €70k base salary + Bonus (up to 10%) + Salary review in 6 months ---- Verde Search are partnering...


  • Dublin, Ireland Deloitte Ireland LLP Full time

    Deloitte is the biggest professional services Firm in the world, and making an impact is more than just what we do: it's why we're here. We're driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. D eloitte has been...


  • Dublin, Ireland IT Search Full time

    Senior Software Engineer Cloud Production Environment Dublin Hybrid onsite/WFH IT Search has partnered with a Multinational Cloud Provider who are expanding their Production environment presence in Dublin and are looking to hire a Senior Engineer with ongoing deep level Development skills to work alongside a highly experienced team of Platform Specialists...


  • Dublin, Ireland Global Professional Consultants Full time

    My client, Irelands top Civil Engineering main contractor based in Ireland and the UK are now searching for a Foreman for a projects in Dublin and Wexford. Role: Manage and supervise on-site teams, including tradespeople and subcontractors, ensuring work is carried out safely and to specifications. Coordinate daily activities, liaising with project managers,...


  • Dublin, Ireland Crédit Agricole Group Full time

    Duties and responsibilities Project Planning and Management • Develop detailed project plans to monitor and track progress in line with CACI project management methodology • Coordinate internal resources and third parties for flawless execution of projects • Ensure resource availability and allocation • Manage changes to project scope, schedule, and...


  • Dublin, Ireland PE Global (UK) Full time

    PE Global are currently recruiting for a Mechanical Project Manager for a leading engineering company involved with complex biopharma facilities. The client is seeking a Project Manager to oversee an upcoming mechanical engineering project in the Longford region, on a permanent, full-time basis. Duties and Responsibilities: - Attend and actively engage in...


  • Dublin, Ireland Novartis Farmacéutica Full time

    When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. If you are passionate about Drug Development and Project Management, then come join the GPM team as a Global Program Associate Director (GPAD)! In Global Program Management (GPM) we...


  • Dublin, Ireland Reperio Human Capital (Ireland) Ltd Full time

    Department: Risk Consulting Role: Programme Recovery & Risk Management Level: Snr. Manager / Director Contract Type: Full Time - Permanent Introduction to the department: This team is part of our client's Risk Consulting practice. They operate across a range of different sectors, including the public, energy and utilities, financial services and telecoms....


  • Dublin, Ireland Amazon Full time

    Security Program Manager, Data Center Security Job ID: 2866916 | Amazon Data Services Spain, S.L. The Amazon Web Services (AWS) Data Center Operations Security Team is seeking a highly talented and motivated physical Security Program Manager (SPM) to join our team. At Amazon, we are working to be the most customer-centric company. To get there, we need...


  • Dublin, Ireland PE Global Full time

    PE Global are looking for a Regulatory Systems Business Support (RSBS) Manager on behalf of our client based in Dublin: 7 Month initial contract This is what you will do: The Manager, Regulatory Systems Business Support (RSBS) is responsible for managing an ongoing Veeva to Veeva regulatory information management system migration. Ensuring all documentation,...


  • Dublin, Ireland Lex Consultancy Ltd Full time

    We are urgently seeking temporary Customer Service staff for a period oftwo - three months in Dublin 2. This role will involve taking calls from members of the public, answering basic queries and noting details for further calls for more complex issues. Fully onsite role - Dublin 2 Working hours - 9am - 5pm Start date - First week of Februaru End date -April...


  • Dublin, Ireland Quanta Consultancy Services Ltd Full time

    Global Regulatory & Operations Lead - Operations Lead - Ireland/Dublin Our client is a global supplier of sterile injectable pharmaceutical products. They currently market and distribute a portfolio of sterile injectable drugs. Our state-of-the-art research and development organization has a robust pipeline of products in development that we will bring to...


  • Dublin, Ireland Nbsalonspa Full time

    Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA) Team collaborates with the Regulatory Affairs Global Regulatory Strategy Group (GRS), Precision Medicine, and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical...


  • Dublin, Ireland Servicenow Full time

    Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global market leader, bringing innovative AI-enhanced technology to over 8,100 customers, including 85% of the Fortune 500. Our intelligent cloud-based...


  • Dublin, Ireland Pfizer Ireland Full time

    JOB DESCRIPTION ROLE SUMMARY Lead and develop the Irish Colleague Wellness (CW) teams, delivering progressive, cutting edge business-relevant colleague wellness health support and innovative occupational health solutions. Develop, implement and monitor effectiveness of Global colleague wellness policy and programs, aligning with global requirements to...


  • Dublin, Ireland Design Build Search Full time

    Design Build Search is seeking aDirector - Project Manageron behalf of our client based in Dun Laoghaire. The selected candidate will provide Project Management services for clients, while working within a busy team supporting and developing the Project Management Practice. This is an excellent opportunity to join a talented and growing team, who have built...


  • Dublin, Ireland Robert Walters Ireland Full time

    Our client is in search of a Regulatory Accountant to join their dynamic team. This role offers an exciting opportunity to work within a wealth management company that is currently experiencing significant growth. You will have the chance to handle a wide range of tasks, providing you with the opportunity to broaden your skill set and develop your...