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My Client a Global Pharmaceutical company based in the midlands are recruiting for a Regulatory Affairs specialist. Applications are invited for the position of Regulatory Affairs specialist.
uality Assurance / Regulatory Affairs Specialist – Carlow or South Tipperary - Support Corporate Regulatory personnel with the preparation of new filings and maintenance of dossiers in the post approval world for global registrations - Provide regulatory direction to the site for products of responsibility
Our Client in Athlone wish to recruit a Regulatory Affairs Specialist who will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for medical products globally.
Provide Regulatory support for the manufacture of Clinical and Commercial pharmaceutical products. Regulatory “Point of Contact” between site and corporate Regulatory personnel, for clinical and commercial small molecules and helping to execute site Regulatory strategy for DS / DP manufactured at the site.
Represent Regulatory Affairs on project/product development teams and will be responsible for the development and implementation of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations.
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The Sr. Regulatory Affairs Specialist will develop strategies for issues related to regulatory processes, compliance activities, documents, submissions, investigations, product development planning and regulatory agency interaction.
Our client is looking for the ideal candidate to fill this key role in supporting department goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to a range of medical devices.
Provide, as required, regulatory input and approval for changes and classification of changes to all documents impacting the QMS - Assisting in preparing and maintenance of Technical Files for product registration and submissions to EU and International Competent Authorities and / or Regulatory Agencies
Our client, a Irish owned organisation are currently recruiting for a Regulatory Affairs and Labelling Specialist to join their team. This is a permanent opportunity and the successful candidate will report directly into the Head of Quality and Regulatory Affairs.
Applications are invited for the temporary (6 month) contract position of Regulatory Affairs Associate II. This CMC regulatory role will involve the coordination, preparation and maintaining of a variety of regulatory CMC submissions to support both development and commercial products.
Applications are invited for the position of Quality Assurance Specialist. - Participate in the preparation for and hosting of regulatory and customer audits - See Job Description - Description - MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
Senior Regulatory Affairs Officer / Consultant - The Senior Regulatory Affairs Officer helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets.
The QC Manager will manage a team of QC specialists and QC analysts to support primarily the microbiological and in process activities for Athlone Drug Product and Biologics facility. The role is also responsible for implementation and support of the QC technical, regulatory and quality systems.
Provide Regulatory support for the manufacture of Clinical and Commercial pharmaceutical products. Regulatory “Point of Contact” between site and corporate Regulatory personnel, for clinical and commercial small molecules and helping to execute site Regulatory strategy.
Interface with key business partners e.g. Manufacturing, Executive Management, Regulatory Affairs, PMS team and other functions as required. Teleflex Medical Job Title: Quality Systems Specialist ISO / Regulatory authority support - Improve and Maintain the quality management system (QMS) in line with ISO13485, ISO9001, 21CFR 820 and Medical Devices Directive.
Reviewing data for technical quality and compliance to protocols, methods and SOPs; reviewing and approving laboratory investigations, deviations, QA facility and data audits; leading client and regulatory audits. Currently our Athlone GMP Contract Laboratory has a rare opening of Laboratory Manager to lead our Inhalation group.
The successful candidate will be a key member in a technical team of specialists and will provide support in the development and validation of analytical test methods used for final product and in-process testing of biopharmaceutical products. Participate in Quality and Safety regulatory audits.
Work closely with specialist contract testing service providers to ensure excellent collaboration is maintained throughout the project - Participate in Quality and Safety regulatory audits.
Laboratory Manager (Food) Large Irish processing and food production operation presents a super career opportunity. Manage lab staff of 15 across all quality functions. Great prospects.
Training on routine operation, maintenance and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines. Seeking an experienced Stability Analyst to be based in a Biopharm department of a GMP Lab in Westmeath. Perm role, excellent package on offer.
Quality Manager - Excellent opportunity with a thriving food manufacturing business. Excellent opportunity for career advancement for the right candidate. Contact Siobhan on 01 8788240.
We are looking for experienced MSLs or Nurse Advisors working within the field of Diabetes or Scientific candidates within the Pharmaceutical industry that will join our fantastic team in Ireland on a permanent full-time basis.
Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required. Prior experience of liasing with key regulatory bodies HPRA, FDA etc - We are currently sourcing a high calibre Senior QC Lab Manager to lead our diverse, technicallab teamin Sligo.
The successful candidate will be responsible for the management, direction and co-ordination of all quality and regulatory activities for the site. - Provide leadership on regulatory topics and application of standards. Circa 10 years' manufacturing experience working in a quality assurance role or related department desired.