Our client is committed to identifying, developing and commercialising healthcare products internationally across a spectrum of therapeutic areas - including pharmaceutical, medical device and nutritional products. Due to continuous company growth and expansion, they are seeking an experienced Regulatory Affairs Officer/Specialist to join the team at their virtual operation in North Dublin.
Duties and responsibilities of the Regulatory Affairs Officer/Specialist will include but are not limited to:
- Create, provide input to and execution of Regulatory Strategies related to existing and new MAA's, medical device licences.
- Preparing and managing international regulatory submissions in accordance with commercialisation plan.
- Plans and prepares regulatory submissions for medical devices and foods for specific target markets for new products, product changes and re-registrations as required.
- Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations.
- Track registrations, variations and Health Authority Commitments, related to company medicinal products and maintaining company Regulatory databases for registrations, variations and commitments.
- Processing queries from licensees and distributors on regulatory matters and supporting them where possible.
- Performing regulatory compliance activities such as SOP revising, gap analysis, reviewing company specifications, change controls etc.
- Review and approval of product labelling, promotional material.
- Receive, review, triage, and process Lifecycle safety operational data. Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure.
- Assist the QPPV/dQPPV with Pharmacovigilance compliance activities.
- Lifecycle maintenance of PV documents such as PBER's, PSUR's, DSUR'S, PSMF updates and Annual Reports.
- Provide support into the preparation of regulatory action in response to urgent safety concerns (e.g. variations, urgent safety restrictions and communications to patients and healthcare professionals).
You will have skills and experience in the following:
- BSc and 4+ years relevant industry experience.
- Knowledge and understanding of the EU regulatory frameworks for medicinal products.
- Knowledge of medical device quality standards would be of distinct advantage.
- Knowledge and understanding of the food supplement legislation would be advantageous.
- International experience of registrations/variations/significant changes of Medicinal Products or Medical Devices.
- Proven experience within Regulatory Strategy and its execution.
- Good understanding of the content and format of MA registration files (CTD and eCTD) with the ability to prepare high quality submissions.
- Previous experience with the preparation and submission of new MAAs, life cycle maintenance in the EU (national/MRP/DCP) and non-EU markets.
- Awareness or knowledge of the EU Guidelines on Good Pharmacovigilance Practices (GVP).
- Excellent interpersonal skills.
- An excellent level of attention to detail and accuracy.
- Proven organisational and planning skills.
- Strong verbal and written communication skills.
- Enjoy and thrive in a fast-paced environment.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.