Regulatory Affairs Manager (5+ yrs exp)
Our client are a Global start-up speciality pharmaceutical company (a subsidiary funded by a multi-billion US global biopharmaceutical company). Due to growth, this organisation requires a Regulatory Affairs Manager to join the team in Dublin on a permanent basis.
Reporting into the Head of Regulatory Affairs and Pharmacovigilance, as RA Manager you will be responsible for the following:
- Regulatory maintenance of EU (MAs) and US NDAs. Maintenance will include items such as generation and submission of Type I and II variations applications in EU and FDA filings.
- Updating CTD registrations.
- Providing Regulatory Affairs support on Change Controls within the company approval system.
- Generation and management of prescribing information, patient information leaflets and packaging components, including artwork management, that are in line with regulatory requirements and company approval systems.
- Participate in technology transfers, validation activities with CMOs, external vendors and internal cross functional teams including Manufacturing & Logistics and Quality departments.
- Supporting corporate acquisitions as needed within a growing biopharma company.
- Provide regulatory support product launches and out-licensing activities in global markets.
- Maintaining a sound knowledge of EU and US regulatory requirements, regulations and guidelines to provide advice internally for matters related to products.
In order to be considered you must have the following:
- 6-8 years practical/hands-on EU and US experience of working in a pharmaceutical regulatory affairs role in the pharmaceutical industry.
- Qualifications: Degree or advances degree in a life-science subject or pharmacy.
- Excellent technical, verbal and written skills
- Self-starter who will work with minimal supervision
- Eligible to work in EU
To discover more about this opportunity, apply online or contact Gillian McMurrough at HRM on +353 1 6321827 for a confidential discussion.
Salary: €60000 - €80000
Location: Dublin City Centre