GRCY-0, Senior Reg Affairs Associate

EMD; South Australia; On-site; AUD 100,000 - 130,000; Full time

Job summary

A leading global healthcare company in Australia is seeking a Senior Regulatory Affairs Associate to join their team. The role involves managing regulatory submissions and ensuring compliance with local regulations while working collaboratively with cross-functional teams. Ideal candidates should possess a Bachelor's degree in life sciences and have significant experience in Regulatory Affairs, particularly with TGA and Medsafe. Join a team dedicated to improving patient outcomes and innovating solutions for rare diseases.

Benefits

Opportunities for personal development

Inclusive company culture

Flexible working environment

Qualifications

• Minimum of 5 years of experience in Regulatory Affairs.
• Experience with TGA and Medsafe applications.
• Proven track record in regulatory approvals, especially for rare conditions.

Responsibilities

• Manage end-to-end regulatory submissions and approvals.
• Lead strategy and execution of regulatory activities.
• Ensure compliance with local regulations.

Skills

Regulatory submissions management

Dossier analysis

Collaboration with cross-functional teams

Knowledge of Australian regulations

Problem-solving

Education

Bachelor's degree in life sciences or pharmacy

Job description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Job Title: Senior Regulatory Affairs Associate

Location: Sydney

Company: Merck Healthcare

Employment Type: Full-Time

• Work with a purpose-driven global healthcare company
• Make a real impact on patients with high unmet medical needs
• Inclusive and collaborative company culture

Join us in our mission to improve the lives of patients with rare diseases!

We are committed to advancing healthcare and developing innovative solutions that address high unmet medical needs and improve patient outcomes, especially for patients with rare diseases.

We are currently seeking a highly motivated and experienced Senior Regulatory Affairs Associate to join our Regulatory Affairs team to lead end-to-end regulatory strategy and activities for our growing portfolio.

What you will do

As a Senior Regulatory Affairs Associate you will be responsible for managing and driving end-to-end regulatory submissions and approvals for pharmaceutical products. You will play a pivotal role in leading the strategy and execution of regulatory activities that enable timely registrations, optimal labelling and seamless lifecycle management.

• Manage pre-submission activities, Category 1 applications to the TGA and Medsafe.
• Perform dossier analysis, lead the strategy and execution of regulatory activities that enable timely registrations, optimal labelling and lifecycle management.
• Collaborate with local cross-functional, regional and global teams to facilitate successful registration, commercialisation and life cycle management of our products.
• Ensure compliance as per local regulations.
• Liaise with the TGA and Medsafe as required.

Main responsibilities

• Manage pre-submission activities, Category 1 applications to the TGA and Medsafe.
• Perform dossier analysis, lead the strategy and execution of regulatory activities that enable timely registrations, optimal labelling and lifecycle management.
• Collaborate with local cross-functional, regional and global teams to facilitate successful registration, commercialisation and life cycle management of our products.
• Ensure compliance as per local regulations.
• Liaise with the TGA and Medsafe as required.

Who you are

Ideally, the candidates should have:

• Bachelor’s degree in life sciences, pharmacy, or a related field, with a minimum of 5 years of experience in Regulatory Affairs.
• Experience in leading the dossier and regulatory strategy for applications to the TGA and Medsafe.
• A proven track record of successful regulatory approvals, especially in rare tumours/diseases, including Orphan Drug Designation applications.
• Experience in leading interactions with the TGA and Medsafe that result in successful regulatory outcomes.
• Experience in drug development and clinical trial application or notification is highly regarded.
• In‑depth knowledge of the Australian regulatory requirements for drug development and registration.
• Strong analytical and problem‑solving
• Ability to work effectively and collaboratively with local cross‑functional, regional and global teams.

How to Apply

If you are passionate about making a difference in the lives of patients with rare diseases, we invite you to apply by sending your resume and cover letter to the link provided below.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!