Rowan O'Brien Email & Phone Number

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

• Direction, administration, budgetary management of the reg affairs (RA) work programme for NN Oceania's medicine and medical devices portfolios. This work mostly pertained to sterile, injectable, innovative prescription medicines of recombinant DNA origin. o New Biological Entity (NBE) registration applications; New Medicine Applications and abbreviated NMAs; cat. 1 and cat. 3 variations; CMNs and SACNs; safety related requests; self-assessable requests; notifications; Good Manufacturing Practice clearance applications; BICON biological substance importation permits; 5G-5H permits to import human growth hormone o successful experience with: orphan drug designation; expedited regulatory pathways such as priority review determination; Comparable overseas regulatory (COR) pathways; ACCESS international work-sharing regulatory pathway. o NSW, Victoria and NZ wholesaler’s licence applications, including drafting of drugs and poisons control plans.• Line management of team of 4 RA professional staff (internal and external) - development and coaching, task setting, performance management and appraisal). • Member of NN Oceania’s ‘Product Launch Committee,’ developing strategies and tactics to drive product portfolios on optimal strategic pathways.• Issues management including medicine shortage and medicine recall activities

Novo Nordisk Pharmaceuticals P/L

I successfully managed the AU and/or NZ registrations and line extensions of an extensive portfolio of now market-leading NBE biopharmaceuticals. My responsibilities and work skills included:• Direction and administration (including budgetary management) of the regulatory affairs and pharmacovigilance programmes, and NovoCare Customer Care Centre operations, for Novo Nordisk’s medicine (diabetes, obesity, haemophilia, growth hormone disorders, women’s health) and medical device portfolios, across Australia and NZ.• Performance of the hands-on activities involved in the registration and maintenance of new biological entity medicines and therapeutic device registrations, with the TGA. These files primarily concern prescription medicines of recombinant DNA origin.• Line management of the professional staff of the RegPV and customer care units through coaching, goal setting, performance appraisal, performance management; development and enhancement of a positive working climate and staff motivation• Participation on inter-departmental project teams dedicated to registration, launch, discontinuation and deregistration.• Day-to-day liaison with TGA personnel from a variety of areas in the Market Authorisation Group and Monitoring & Compliance Group. • Internal and external auditing activities (qualified lead auditor).• Document (standard operating procedure) development and implementation. • Issues management including (in my capacity as NN Australia+NZ Recall Co-ordinator) responsibility for the application of the TGA's Uniform Recall Procedure for Therapeutic Goods.

Sydney, Australia

Sydney, Australia

Master, Medical Science (Drug Development)

Bachelor Of Science With Honours, Zoology/Parasitology