Current jobs related to CMC Manager - Dublin, Dublin City - The RFT Group
-
Senior Professional RA CMC
3 days ago
Dublin, Dublin City, Ireland Leo Pharma Inc. Full timeSelect how often (in days) to receive an alert:Application deadline:16.07.2025Location:DublinD12 E923,Ireland,IrelandContract type:PermanentJob ID:3312Role DescriptionSenior Professional RA CMCWe invite you to join our Global CMC Regulatory team in Dublin or Gdansk as a Senior Specialist RA CMC, where you will shape the global regulatory CMC strategy for a...
-
Senior Professional RA CMC
2 days ago
Dublin, Dublin City, Ireland LEO Pharma Full timeSocial network you want to login/join with:We invite you to join our Global CMC Regulatory team in Dublin or Gdansk as a Senior Specialist RA CMC, where you will shape the global regulatory CMC strategy for a biological drug product. Build the LEO Pharma of tomorrowAt LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become...
-
Dublin, Dublin City, Ireland Viatris Full timeDirector Global CMC Strategy – Based Anywhere in EuropeJoin to apply for the Director Global CMC Strategy – Based Anywhere in Europe role at ViatrisDirector Global CMC Strategy – Based Anywhere in Europe2 days ago Be among the first 25 applicantsJoin to apply for the Director Global CMC Strategy – Based Anywhere in Europe role at ViatrisGet...
-
Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland STRIVE Full time1 week ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from STRIVE SearchQualified Scientist & Principal Recruitment ConsultantHelping professionals find the next step in their career, while fulfilling top client…Regulatory Affairs Manager - Global CMCCo. Dublin - HybridOur...
-
Regulatory Affairs Manager
2 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJOB 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...
-
Dublin, Dublin City, Ireland beBeeRegulatory Full timeJob TitleSenior Regulatory Affairs Specialist CMCWe are seeking a highly skilled Senior Regulatory Affairs Specialist CMC to join our team. As a key member of our Global Regulatory Team, you will be responsible for shaping the global regulatory CMC strategy for a biological drug product.This is an excellent opportunity for an experienced regulatory...
-
Reg Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland Sigmar Recruitment Full timePosition Overview:We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team and ensuring compliance with applicable requirements for our pharmaceutical products.This position...
-
3 Days Left Reg Affairs Manager
2 weeks ago
Dublin, Dublin City, Ireland Sigmar Recruitment Full timePosition Overview:- We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team and ensuring compliance with applicable requirements for our pharmaceutical products.- This...
-
Regulatory Affairs Manager
4 days ago
Dublin, Dublin City, Ireland Cpl Full timeRegulatory Affairs Manager - NEW OPPORTUNITY Thornshaw Scientific, on behalf of their client, a global pharmaceutical company, has a new opportunity for a Regulatory Affairs Manager to join their team in Dublin.This is a full-time, hybrid position reporting to the Global Regulatory Affairs Associate Director.Responsibilities: Lead planning, execution,...
-
Regulatory Affairs Consultant
2 days ago
Dublin, Dublin City, Ireland Parexel Full timeSocial network you want to login/join with: Regulatory Affairs Consultant - CMC biologics (home or office based), Dublincol-narrow-left Client: Parexel Location: Dublin, Ireland Job Category: Other-EU work permit required: Yescol-narrow-right Job Reference:f539f003a631 Job Views:6 Posted:21.06.2025 Expiry Date:05.08.2025col-wide Job Description: When our...
CMC Manager
1 month ago
Social network you want to login/join with:
Our client is young ambitious pharmaceutical company with a strong record of success in drug development. The newly appointed CMC Manager will report to the Associate Director – Technical Operations and will manage pharmaceutical development and pharmaceutical technology projects to deliver development pipeline and support existing commercial products. Manage pharmaceutical development projects primarily with respect to validation and commercialization of new products. Manage pharmaceutical technology projects, primarily coordinating continuous improvement activities at CMOs.
Job Spec
· Lead drug product validation and commercialisation activities for new pharmaceutical development projects.
· Lead continuous improvement projects for commercial products
· Support the development and manufacture of pharmaceutical dosage forms and devices.
· Consistent with FDA standards, support the process validation of to-be commercial drug products. In addition, when changes have been made to the manufacture of commercial drug products, support the re-validation of such products.
· Support the technical transfer of commercial manufacturing and analytical testing of drug products.
· Support the preparation of regulatory filings such as INDs, ANDAs, NDAs and supplements.
· Stay current with emerging technology and regulatory guidance within industry.
· Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance.
· Support the preparation of the Pharmaceutical Development & Pharmaceutical Technology budget.
· Represent Pharmaceutical Development & Pharmaceutical Technology in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner.
· Contribute to the review of company policies and procedures.
· Undertake any other duties, which may be assigned by Senior Management.
LEARNING & DEVELOPMENT
· Actively engage in an individual development / personnel improvement plan.
· Actively engage in the continuous improvement / 5S / 6 sigma programme.
· Ensure training has been received in relation to specific duties.
HUMAN RESOURCE MANAGEMENT
· Adhere to the Company's policies and procedures.
HEALTH & SAFETY
· Understand and follow the company's Health & Safety policies.
· Comply with the environmental management system and minimise environmental impact where possible.
QUALITY
· Comply with all aspects of the Quality System.
· Ensure that a 'quality culture' and an appreciation of the quality system is installed within the manufacturing department.
CORPORATE
· All employees are expected to work towards the company vision and adhere to the core principles of building strong teams of empowered people, communicating effectively, demonstrating trust and respect, developing peoples knowledge and expertise, demonstrating excellence in leadership and exhibiting a positive attitude.
Person Spec
· The preferred candidate will have a degree in Chemistry, Analytical Chemistry, Pharmacy or related equivalent at 2.1 or higher master's degree in chemistry or related equivalent PhD in Chemistry or related equivalent
· At least 5 years practical experience of working in pharmaceutical development or manufacturing. At least 2 years practical experience of drug product Process Performance Qualifications and associated activities. Hands on experience is required in the manufacture of drug products, and execution of PPQ / Validation batch manufacture.
· You will have a strong knowledge of ICH, FDA and EMA Process Performance Qualification and Process Validation guidelines, as well as a strong knowledge of ICH, FDA and EMA guidelines relating to Pharmaceutical Development
· 10+ years practical experience of working in pharmaceutical development or manufacturing. At least 5 years practical experience of drug product Process Performance Qualifications and associated activities. Practical experience of packaging Line Trials and Validations. Practical knowledge and experience of drug product Serialization requirements
· Preparation and execution of Process Performance Qualification protocols and reports for Oral Solid Dosage forms. Good knowledge of statistical considerations ie Design of Experiments, ASTM E2709/E2810
· At least 2 years' experience managing pharmaceutical projects at a Contract Manufacturing organisation. Use of DoE methodology in in evaluation and determination of process Design Space and Control Strategies. Experience writing Module 3 Regulatory Submission documentation.
· Demonstrable IT skills ie Office. Knowledge and understanding of statistical software applications ie MiniTab. Proven communication skills (written and verbal). Proven ability to maintain high standards of work and attention to detail. Demonstrable planning, organization and time management skills. Demonstrable ability to work with and influence CMOs.
· Must be able to work individually and as part of a team. Ability to work proactively and under time constraints. Good interpersonal skills
#J-18808-Ljbffr