Regulatory Affairs Project Lead

5 days ago

Sydney, New South Wales, Australia Johnson & Johnson Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of our Regulatory Affairs team, you will be responsible for leading the development and implementation of regulatory strategies for a portfolio of products.

You will work closely with cross-functional teams to ensure that regulatory submissions are of high quality and meet the required standards. Additionally, you will provide regulatory guidance and expertise to other functions within the company.

This is an excellent opportunity for a motivated and experienced Regulatory Affairs professional to take on a challenging role and contribute to the success of our team.

Responsibilities
  1. Lead the development and implementation of regulatory strategies for a portfolio of products.
  2. Collaborate with cross-functional teams to ensure that regulatory submissions are of high quality and meet the required standards.
  3. Provide regulatory guidance and expertise to other functions within the company.
  4. Ensure that all regulatory work is undertaken in compliance with local regulations and corporate standards.
  5. Maintain a good understanding of the regulatory environment and guidelines.
Requirements
  • Bachelor's Degree in Pharmacy or Science or a related field.
  • Extensive previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand.
  • Demonstrated strong technical expertise working with the TGA and Medsafe.
  • Natural growth mindset - you thrive on challenge and see failure as a springboard for growth and developing your abilities.
  • Positive can-do attitude and are self-motivated 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 internal and external stakeholders, ability to shape outcomes and deliver results.
  • Extremely strong ethical values.
About Our Company

Johnson & Johnson is a global healthcare leader driven by a passion to change the trajectory of health for humanity. We believe in the power of collaboration and are committed to working with others to improve the health of people around the world.

We are a company that is driven by innovation, and our products and services are designed to meet the needs of healthcare professionals and patients. We are committed to making a positive impact on the lives of people everywhere.

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