Regulatory Affairs Manager (Biotechnology)

Location: Sydney, New South Wales, Australia

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering innovative medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Execute local regulatory strategies and filing plans for marketing authorization and lifecycle maintenance activities.
• Plan and manage regulatory submissions in line with Australian requirements and corporate standards.
• Develop, review, and approve local product labeling and country artwork.
• Act as a point of contact with regulatory agencies and support agency interactions.
• Review promotional and non-promotional materials and monitor regulatory changes affecting hirify.global products.
• Collaborate with clinical, regional, global, quality, compliance, pharmacovigilance, distributor, and vendor stakeholders.

Requirements

• Doctorate or Master’s degree in a scientific discipline with at least 3 years of directly related experience, or a Bachelor’s degree with at least 5 years of directly related experience.
• In-depth knowledge of country legislation and regulations relating to medicinal products.
• Knowledge of regulatory principles, policies, procedures, and SOPs.
• Understanding of registration procedures for clinical trial applications, marketing authorizations, and lifecycle management.
• Understanding of drug development and the ability to communicate scientific and clinical information.
• Strong teamwork, communication, negotiation, influencing, conflict-resolution, and cross-cultural collaboration skills.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Opportunities to learn and progress across a global organization.
• Diverse and inclusive community where employees are empowered to contribute ideas and act.
• Total rewards covering health, financial and wealth planning, work-life balance, and career benefits.
• Full-time 12-month contract with possibility of extension.