Regulatory Affairs Manager

Overview

Lundbeck Australia is seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product portfolio. This role is critical in ensuring compliance with local regulatory requirements for Lundbeck’s products, overseeing regulatory submissions, maintaining licences and liaising with government authorities. The Regulatory Affairs Manager plays a key role in ensuring product approval, lifecycle management and alignment with industry standards while supporting the business strategic objectives. Reporting to the Medical Director, we are looking for an individual with a passion for the CNS and neurology therapy areas.

Your new role

In your new role, your areas of focus:

- Prepare, review, and submit regulatory applications and dossiers to health authorities (TGA, Medsafe, PBAC, PHARMAC).

- Monitor marketing application progress and maintain licenses for imported goods.

- Analyse scientific content of registration packages to ensure regulatory compliance.

- Liaise with government departments and consultants to facilitate product approvals and reformulations.

- Negotiate with regulatory bodies on product information, storage, shipment, and quality standards.

- Respond to investigations and queries related to product integrity, packaging, and storage.

- Review and approve promotional materials in line with Medicines Australia’s Code of Conduct.

- Support phase 3 clinical trials by managing CTNs and liaising with the TGA and CROs.

- Lead internal audits and represent the affiliate in global QA forums.

- Maintain SOPs, Crisis Management documentation, and Risk Management Plans.

- Provide training to new employees on regulatory processes and requirements.

- Monitor regulatory changes and assess business impact.

Your future team

You will be part of a passionate and purpose-driven medical team committed to excellence and innovation in the pharmaceutical industry. You’ll contribute to an expanding portfolio with a forward-looking focus on neuro rare disease breakthroughs. The teams collaborative culture fosters creativity, professional growth, and cross-functional synergy across the organisation. Lundbeck Australia’s local headquarters is proudly located in North Ryde, Sydney.

What you bring to the team

The ideal candidate will possess:

- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or Regulatory Affairs (Master’s preferred).

- 3–5 years’ experience in Regulatory Affairs within the pharmaceutical, biotech, or healthcare industry.

- Strong understanding of Australian and New Zealand regulatory environments.

- Proven success in regulatory submissions and product approvals (Category 1 and 2).

- Strategic thinker with excellent analytical, negotiation, and communication skills.

- Experience in neuro rare or rare disease regulatory submissions is highly desirable but not essential.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We aim to accelerate progress in addressing the big unmet needs of people living with brain disorders, offering rewarding careers with a mix of exciting tasks and development opportunities balanced with well-being initiatives.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

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