Regulatory Affairs Specialist
|Job Title:||Regulatory Affairs Specialist|
|Contact Name:||Laurentina Kennedy|
|Job Published:||about 2 years ago|
Our Client is currently recruiting for an experienced Regulatory Affairs Officer. The company has a number of Medicinal products, medical devices, Food Supplements and Food for Special Medical Purposes within its internationally marketed product portfolio.
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Officer will be joining a small regulatory team and will be responsible for preparing and maintaining the company's product registrations for designated territories in
accordance with the guidelines laid down by national regulatory authorities and providing regulatory support to other areas of the business as needed.
Key Regulatory Affairs Tasks and Areas of Responsibility
Reviewing data to ensure suitability of dossiers/technical files for submission
Preparing and managing international regulatory submissions in accordance with commercialisation plan
Renewing and updating product certificates/authorizations in company's territories
Providing regulatory support for out-licensing activities in EU and non-EU territories
Performing regulatory compliance activities such as SOP revising, gap analysis, reviewing company specifications, change controls and involvement with IDMP project and eCTD.
Reviewing and approving assigned promotional materials for company products
Preparation and submission of new MAAs (Well-established Use) in the EU using DCP route
Preparation and submission of variations within EU and non-EU territories
Managing post-licensing activities (variations, renewals, PSURs, etc.) within EU and Non-EU territories
Preparation of technical submissions in accordance with current Medical Device Directive requirements or relevant national legislation including Design Dossiers, Technical Files and Substantial Change Notifications.
Other company activities
Preparation of Food for Special Medical Purposes applications for reimbursement
Food Supplement labelling updates/reviews and notifications to the relevant Competent Authorities
You will have at least 4 years regulatory experience in the pharmaceutical industry and have a life science or pharmacy degree.
Skills & Competences:
The successful candidate will possess the following:
Knowledge and understanding of the EU regulatory frameworks for medical devices and medicinal products.
International Experience of registration/variation of Medicinal Products and Medical Devices
Good understanding of the content and format of MA registration files (CTD) with the ability to prepare high quality submissions
Practical experience of registration and variation procedures in the EU (national/MRP/DCP) using electronic applications (both NeeS and eCTD).
Previous experience with the preparation and submission of new MAAs
(Well-established Use) in the EU using DCP route
Knowledge of classifying products
Accuracy and attention to detail
Professional Effective verbal and written communication skills
Effective organisational and planning skills
Enjoy and thrive in fast paced environment
Good interpersonal skills, ability to work with others and independently
Self-motivated, self-driven and "can-do attitude"
Excellent IT skills in word processing, excel, PDF software such as Adobe, document management
Previous Project Management Training
Awareness and/or experience of submitting product file through the Advisor Committee on Borderline Substances (ACBS) or HSE Foods Review Group
Previous experience or training in Good Manufacturing Practice, Internal/External Auditing
Experience managing compliance audits
For further information on this Regulatory Affairs Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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