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Galderma

Senior Regulatory Affairs Manager

Reposted 13 Days Ago
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Remote
Hiring Remotely in North Sydney, NS, CAN
Senior level
Remote
Hiring Remotely in North Sydney, NS, CAN
Senior level
The Senior Regulatory Affairs Manager leads regulatory operations in Australia and New Zealand, ensuring compliance with TGA and Medsafe, and managing submissions across pharmaceuticals, medical devices, and cosmetics while mentoring a regulatory team.
The summary above was generated by AI

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

 

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

 

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Our Story

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 is a critical leadership role 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 strong 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

  • Strong 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

We are committed to providing a competitive and attractive remuneration package, complemented by a range of benefits designed to support your growth and wellbeing:

  • 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?

You will be working for an organisation that embraces diversity & inclusion. 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

Ready to make an impact?

Apply now and join us in shaping the future of dermatology.

  • If your application is successful, our recruiter will reach out to you directly for an initial conversation

  • Next, you’ll have a virtual or face‑to‑face discussion with the hiring manager

  • The final stage is a panel discussion with the extended team

Our people make a difference.

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos are the perfect environment for people to thrive and excel in what they do.

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