Regulatory Affairs Manager
MAIN PURPOSE: Key position leading Regulatory and local operational quality activity of exciting portfolio of products. Reporting in a matrix structure to both HQ and locally to General Manager, bringing a new presence to Regulatory and local quality operations for the affiliate. KEY RESPONSIBILITIES: Ensuring products meet regulatory and compliance requirements for the Australia and New Zealand markets.
Managing the preparation of high quality documentation for all regulatory submissions, following current best practice standards. Leading submission strategy and plans for the Regional Commercial unit. Responsibility for all staff in ANZ Regulatory team, including recruitment, supervision, work flow, appraisal and development.
Responsibility for and participation in preparing annual budget or the RA department activities. Representing regulatory and local quality operations (e.g.
Good Distribution Practice related activity) in local cross-functional committees. Being a trusted ambassador representing Norgine in the healthcare community. Requirements QUALIFICATIONS & REQUIREMENTS: Degree in Pharmacy and/or relevant life sciences or equivalent is essential.
Prior experience as a Regulatory Affairs Manager (or similar) within pharma. A full strategic understanding of the drug development principles and processes, including knowledge of the scientific methods applied to clinical research and the current legislative / regulatory controls. Experience of working on major regulatory applications in Australia and New Zealand.
Solid knowledge of pharmaceutical industry and the role of Regulatory Affairs. Strong interpersonal skills to work as a member of the AUS/NZ Management Team. Line Management experience.
Customer oriented. ESSENTIAL SKILLS & ABILITIES: Strong project management skills. Strong attention to detail.
Excellent communication and presentation skills are essential. Collaborative, team-oriented approach, able to develop and support relationships across the organisation as well as with key external stakeholders and the healthcare community at large. Confident, active contributor to cross-functional teams and/or experience working in matrix organizations will be an advantage.
Working knowledge of the responsibilities and operational work of an affiliate’s dedicated regulatory function. Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general..