Regulatory Affairs Associate

Summary about this job

Detail information about job Regulatory Affairs Associate. Terms and conditions vacancy

• Onsite Parking
• Leading Bayer Portfolio
• For us, everything starts with Life

Join Bayer for a better life!

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

As an employer of choice, Bayer will provide you:

• Competitive salary package and benefits;
• Opportunities for ongoing learning and career development.

The Role:

Here's your window of opportunity to be part of our journey. For us, everything starts with Life. We are looking for a person with a winning mindset to join our prescription medicines regulatory team in our Sydney Pymble office. You will be responsible for the end to end management of a portfolio of innovative products. You will ensure that all local products comply with all local and Global regulatory requirements. In addition to this, you will maintain compliant product licenses in a timely manner. This is a 12 month contract.

You will be responsible for:

• Critically appraising dossier packages and identifying and resolving any deficiencies prior to submission to the regulatory authority;
• Maintaining registration for existing products and submitting new registrations to the TGA and Medsafe for prescription medicines
• Responsible for all regulatory activities for products in your assigned portfolio
• Provide advice to stakeholders on potential areas of regulatory concern and new regulatory developments
• Providing sound strategic regulatory advice and support to other company functions e.g. global regulatory affairs, business development, manufacturing.
• Developing and maintaining trust and effective working relationships with both internal and external customers.
• Reviewing promotional materials according to the relevant legislation and Industry codes of conduct and assisting with key message development and marketing strategy.

Skills and experience required

• 2-5 years experience working with prescription medicines in Australia and New Zealand;
• Tertiary qualifications in pharmacy or a science related discipline;
• A working knowledge of current Australian and New Zealand regulatory guidelines and legislation;
• Attention to detail with good verbal and written communication and excellent project management skills;
• A passion for excellence and driving innovation

Who you are:

Join us if you have a qualifications in Science, Engineering or Pharmacy, are engaging, insightful, forward thinking and have an eye for detail. You will be adaptable, have a winning mindset and a strong interest in working in a dynamic environment.
Your application:

Your application:

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now.


PASSION TO INNOVATE |POWER TO CHANGE