Regulatory Affairs Strategist

7 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $104,000 - $130,878
Job Opportunity

This is an exciting opportunity for a Regulatory Affairs Project Manager to lead a product portfolio, plan regulatory strategies and manage local regulatory submissions for Australia and New Zealand.

About the Role

We are looking for a skilled individual who can work collaboratively with colleagues in the management of applications throughout the submission and evaluation processes to ensure a high quality and timely outcome.

  • Develop and execute strategies for pipeline products to optimise and accelerate launch excellence
  • Lead ad-hoc departmental projects and initiatives including regulatory consultations and projects initiated by global/regional teams
  • Provide guidance and expertise to other functions within the organisation to deliver outcomes
  • Maintain a good understanding of the regulatory environment and guidelines
Key Requirements

We require someone with a Bachelor's Degree in Pharmacy or Science or related field, and any additional qualifications such as a PhD or Masters would be highly regarded.

Extensive previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand.

Demonstrated strong technical expertise working with regulatory bodies.

A growth mindset – you thrive on challenge and see failure as a springboard for growth and developing your abilities.

Positive attitude and self-motivation with a sense of urgency.

Excellent verbal and written communication skills.

Strong project management skills including critical thinking and problem solving, negotiation, time management and risk management.

Demonstrated ability to lead from the front, connect with key stakeholders, ability to shape outcomes and deliver results.

Strong ethical values.

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