Senior Regulatory Affairs Manager (New South Wales)

Senior Regulatory Affairs Manager (New South Wales)

16 Aug
|
Galderma
|
New South Wales

16 Aug

Galderma

New South Wales

At Galderma, we're advancing dermatology for every skin story. As the pure-play dermatology leader in 90+ countries, we deliver science-based innovation across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Our portfolio includes trusted brands like Cetaphil, Benzac, Alastin and more.

Galderma ANZ has proudly been recognised as a Great Place to Work® 2025.

About the Job

We are seeking a Senior Regulatory Affairs Manager - ANZ to join our team based in Sydney, Australia. This critical leadership role is responsible for providing strategic regulatory direction across Australia and New Zealand, ensuring timely patient access, regulatory compliance, and strong partnership with business and global stakeholders. You will lead local regulatory operations while remaining hands‑on, with a core focus on pharmaceuticals and medical devices across the portfolio.

Key Responsibilities

- Provide strategic regulatory leadership to the ANZ Country Leadership Team, aligning regulatory strategies with business priorities
- Lead and execute end‑to‑end regulatory submissions and lifecycle maintenance across pharmaceuticals, medical devices and, where applicable, cosmetics
- Manage all local regulatory operations, ensuring high‑quality, timely submissions and ongoing compliance with TGA and Medsafe requirements
- Act as the key regulatory interface with health authorities, overseeing negotiations, responses, audits and inspections
- Lead,



coach and develop regulatory team members, while building solid cross‑functional and global stakeholder relationships

Ideally you will have

- A Bachelor's degree in Pharmacy, Life Sciences or a related field (Master's degree desirable)
- 10+ years' experience in Regulatory Affairs within pharmaceuticals and medical devices (cosmetics experience advantageous)
- Proven experience leading end‑to‑end product registrations and regulatory strategy in Australia and New Zealand
- Robust people leadership capability, with experience managing or mentoring small, lean teams
- Excellent stakeholder engagement skills with the ability to balance commercial objectives and regulatory compliance

What we offer in return

- Career development opportunities
- Paid parental leave
- Additional leave to celebrate your birthday
- Sydney Harbour office views with a flexible hybrid work policy
- Dermatology treatments from Galderma's world‑leading aesthetics portfolio, twice per year
- Generous discounts on our premium products

Why Join Us?

We believe we deliver better outcomes by reflecting the perspectives of our diverse customer base.

- Proudly recognised as a Great Place to Work® - 2025
- Be part of a global leader and play a key role in shaping the future of skin health
- Work with premium brands trusted worldwide
- Grow your career in a culture that values excellence, innovation and collaboration

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📌 Senior Regulatory Affairs Manager (New South Wales)
🏢 Galderma
📍 New South Wales

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