Job Description
Regulatory Affairs Manager, Pharma
required to oversee all regulatory activities and projects within defined time schedules and in accordance with internal procedures, agreed deadlines and legislative requirements.
The successful candidate will manage the regulatory team and lead assigned regulatory projects including management of budget, time-lines and submission planning.
This is a permanent role based in Munster.
Responsibilities of Regulatory Affairs Manager:
Proactively communicate regulatory strategy, key issues and any other critical topics to Managing Director
Take the lead in health authorities’ interaction and relationship building
Supporting pharmacovigilance activities, EVMPD, Medical Information, clinical and non-clinical work (includes writing / review of clinical overview and clinical summary documents)
Management of training and mentoring of junior regulatory employees to ensure they are competent and confident in providing service excellence within the sector.
Requirements for Regulatory Affairs Manager:
BSc or pharmacy primary degree.
7+ years’ experience of cross-functional Regulatory Affairs in the Pharmaceutical Industry. Pharmacovigilance and or medical devices would be a distinct advantage
Excellent project management skills with the ability to oversee multiple projects simultaneously.
A proactive approach with the ability and experience to manage a diverse team of professionals
A proven track record in communicating with top level management and competent authorities
Solid understanding and experience of eCTD submissions
Strategic thinking as well as hands-on experience with different registration procedures
Demonstrate professionalism and leadership at all times.
Please phone Larry on +353 1 2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.