Regulatory Affairs Manager - NEW OPPORTUNITY

County Dublin, Leinster Cpl

Job Viewed

Tap Again To Close

Job Description

workfromhome
Regulatory Affairs Manager - NEW OPPORTUNITY

2 days ago Be among the first 25 applicants

Job Description Form

Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.

Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.

Job Description Form

Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.

Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.

The role & Responsibilities:

To take lead role and responsibility for the effective planning, execution, tracking and reporting of assigned operational registration and life-cycle management projects for company Products.

Promote high quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning and delivery of GRA and Corporate projects. Positive approach and attitude in a global multi-stakeholder company to help deliver high quality and timely registrations, local and global team build and support corporate growth and patient treatment options. Line Management of more junior team member (internal and external).

  • Acts as responsible Manager in the Regulatory Team member for assigned regulatory projects.
  • Effectively plans, manages, and delivers assigned project workload.
  • Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, publishing, CMC authoring and or updates as required in line with corporate needs and timelines.
  • Effective high-quality communication with Regulatory Authorities and internal BH functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices.
  • Effective high-quality communication with external partners on ad hoc basis

Qualifications & Experience:

Pharmacy or Scientific Primary and /or advances Degree(s).

>5 years human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and /or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).

Writing and preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling Experts.

Experience of EU DCP and MRP MAAs.

Project management experience.

Excellent communication skills.

For full details please email your CV to (email protected) or call Tina at +353 1 2784701

Thornshaw Scientific is a leading life sciences agency and part of the CPL Group of companies.

Seniority level
  • Seniority level Mid-Senior level
Employment type
  • Employment type Full-time
Job function
  • Job function Legal
  • Industries Staffing and Recruiting

Referrals increase your chances of interviewing at Cpl by 2x

Get notified about new Regulatory Affairs Manager jobs in Dublin, County Dublin, Ireland .

Dublin, County Dublin, Ireland 1 week ago

Senior Manager - Head of Compliance (PCF 12 / PCF 52), Etsy Payment Ireland Limited

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 17 hours ago

Dublin, County Dublin, Ireland 3 days ago

Dublin, County Dublin, Ireland 2 weeks ago

Compliance & Risk Manager, AIFM (4 or 5 days) exclusive role

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 4 days ago

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 1 week ago

Regional AML Compliance Manager - Ireland

Dublin, County Dublin, Ireland 2 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Job No Longer Available

This position is no longer listed on WhatJobs. The employer may be reviewing applications, filled the role, or has removed the listing.

However, we have similar jobs available for you below.

Director, Program Operations Leader - Early Phase Clinical Trials

Dublin, Leinster Regeneron Ireland DAC

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Be responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight. To be considered, you must possess: A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $0.00 - $0.00
This advertiser has chosen not to accept applicants from your region.

Clinical Research Nurse - Cardiology (CNM2)

Dublin, Leinster Mater Private Hospital Group

Posted today

Job Viewed

Tap Again To Close

Job Description

Be a Heart Research Hero: Clinical Research Nurse (Cardiology) Join our passionate team at the forefront of cardiovascular research! As a Clinical Research Nurse (CNM2) at the Mater Private Hospital's Cardiovascular Research Institute Dublin, you'll play a pivotal role in driving advancements in heart health. Why you'll thrive here: Make a tangible difference in the lives of cardiac patients through groundbreaking research. Collaborate with a dedicated team of researchers and clinicians in a dynamic environment. Gain valuable experience in clinical research methodologies and contribute to impactful publications. Utilise your strong clinical skills and organisational talents to ensure smooth study execution. Responsibilities: Work alongside investigators to recruit participants for clinical trials in cardiology. Manage research databases and ensure accurate data collection. Coordinate patient study visits, adhering to protocols and regulations. Educate and support patients throughout the research process. You're a great fit if you have: A minimum of 5 years' experience as a Registered General Nurse with the NMBI. At least 2 years' experience in cardiology care. Proven clinical and managerial skills with a keen interest in research. Excellent interpersonal and communication abilities to build rapport with patients and colleagues. Strong organisational skills and a meticulous attention to detail. Bonus points for: Prior experience in clinical research. Postgraduate qualifications in research or cardiology. The Mater Private Network offers: Competitive salary and benefits package. Opportunities for professional development and training. A supportive and collaborative work environment. Be part of a team making a real difference in healthcare. Ready to join us? We look forward to receiving your CV! Mater Private Network is an Equal Opportunities Employer Skills: Research Nurse Manager
This advertiser has chosen not to accept applicants from your region.

Clinical Research Nurse (CNM II)- Cardiology

Dublin, Leinster €44846 - €53151 hour recruitNet

Posted 357 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent
RecruitNet International Ltd   Specializing in relocating qualified professionals throughout Ireland and overseas, we guide you through the We the RecruitNet team are always on call to help you find your perfect job and are staffed by highly experienced and professional nursing recruitment consultants.  Provide clinical treatment to patients with varying degrees of heart failure as a member of a multidisciplinary team, this role will prioritize research and the provision of healthcare services.Research initiatives in cardiac therapy.Participant recruiting, database administration, and study visit coordination will all be a part of this multidisciplinary team role. RequirementsBe on the live register with NMBI.Minimum of 5 years post-registration experience. Strong interpersonal & communication skills.A minimum of two years at least after registration in a treatment field related to cardiology.Capabilities in management and leadership.BenefitsFully Funded Private Health InsuranceGenerous SalariesEducational SupportExcellent Career OpportunitiesProvide exceptional patient care in an environment where quality, respect, caring, and compassion are at the centre of all that we do.
This advertiser has chosen not to accept applicants from your region.

Clinical Nurse Manager 1 - Research Nurse

Dublin, Leinster Childrens Health Ireland

Posted today

Job Viewed

Tap Again To Close

Job Description

Purpose of the Role Clinical research is essential to provide an evidence base for improved medicines and treatment of sick children. It is well accepted internationally that hospitals active in research and innovation are associated with better outcomes for patients and better recruitment and retention of staff. As Ireland's largest paediatric hospital and the leading centre in Ireland for the conduct of clinical trials and studies in children and young adults, CHI has placed excellence in research and innovation as one of its key strategic objectives. As part of ongoing development at CHI towards the opening of the new Children's Hospital, a rationalisation and integration of the existing clinical research infrastructure across all sites is being undertaken. Under the leadership of the CHI Director of Research & Innovation, a new Research & Innovation Office (RIO) and Clinical Research Centre (CRC) are being set-up within CHI and will bring all aspects of clinical research infrastructure together under a single governance and management structure. The Clinical Research Centre is the forerunner of the new paediatric Clinical Research Facility (CRF) that will be embedded in the new Children's Hospital. The CRC is made up of a team of research staff working across CHI sites to support clinical teams in the conduct of clinical trials and other clinical research studies that require specialist expertise and support. The Clinical Research Nurse is a key part of this team, working to support Investigators and research teams with clinical research activities. They will act as the primary advocate for the patient, both prior to and throughout their participation in a research study or clinical trial. As part of a team of Research Nurses, they will work closely with the CRC Operations Manager, Project Managers, Research Nurses and Research Coordinators, ensuring that study activities are carried out effectively and in compliance with Good Clinical Practice (GCP) standards. They will have particular focus on assisting the Principal Investigator to enrol patients to studies and clinical trials and schedule and conduct study visits, ensuring patient safety throughout and maintaining the Investigator Site File. Throughout the research study lifecycle, this role will provide continuity back-up and support as required to other Clinical Research Nurses and Coordinators to ensure the smooth running of research activities from set-up through to closeout, across the portfolio. This is an exciting opportunity to work within a highly motivated team and a dynamic environment, and to be involved in bringing advancements in health outcomes for children and young adults in Ireland. The role offers opportunities for ongoing professional development and the successful candidate will be provided with training and mentoring specific to their role. Essential Criteria: Be registered in the Children's division of the active register of Nurses & Midwives maintained by the Nursing and Midwifery Board of Ireland (Bord Altranais agus Cnimhseachais na hireann) OR Be registered in the General Division of the active register held by NMBI and have relevant children's nursing experience AND At least 3 years post registration experience or equivalent relevant experience. Have the clinical, managerial and administrative capacity to properly discharge the functions of the role Demonstrate evidence of continuing professional development at the appropriate level To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Clinical trials Jobs in County dublin !

 

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Clinical Trials Jobs View All Jobs in County Dublin