Senior Regulatory Affairs Manager

vor 3 Wochen

Sydney, Österreich I-Pharm Consulting Vollzeit

Pharmaceuticals & Medical Devices (Healthcare & Medical)
Join a leading global healthcare company as a Senior Regulatory Affairs Manager and play a pivotal role in driving regulatory affairs initiatives.
In this role, you'll be responsible for ensuring product compliance across key markets while optimizing regulatory strategies to support efficient product approvals and successful market entry.
This is an exceptional opportunity to lead impactful regulatory efforts within a highly respected organization dedicated to advancing healthcare solutions worldwide.
Key Responsibilities:
Lead and manage the regulatory affairs strategy to ensure compliance with applicable regulations for medical devices and other healthcare products in Australia and New Zealand.
Preparation and submission of new product registrations, maintenance activities for medical devices, pharmaceutical products within the portfolio.Evaluate content of new registration packages to ensure alignment with regulatory standards.Recognising, reporting and documenting adverse findings and other medico vigilance and pharmacovigilance relevant information and Technical Product Complaints.Reviewing and approving marketing material to meet TGA code.Collaborate with cross-functional teams to provide regulatory insights that support strategic goals.Develop, maintain and strengthen working relationships with health authorities and industry bodies in ANZ.Manage relevant market access activities.Act as a primary liaison with regulatory authorities, managing inquiries and compliance expectations.Knowledge, Skills & Experience: Bachelors degree in Pharmacy, Science or Engineering.Minimum 5+ years regulatory experience in the healthcare industry in the field of medical device/pharmaceuticals.Extensive knowledge and experience across TGA & Medsafe regulations, particularly relating to registrations.Understanding of business strategy and commercial requirements for effective management of RA portfolio.Deep understanding of regulatory requirements for medical devices and prescription medicines.Strong relationship development with global teams. #J-18808-Ljbffr

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