Senior Regulatory Affairs Manager

Reposted 7 Days Ago
Be an Early Applicant
Hiring Remotely in North Sydney, NS, CAN
Remote
Senior level
Pharmaceutical • Manufacturing
The Role
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.
Summary Generated by Built In

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.

Skills Required

  • Bachelor's degree in Pharmacy, Life Sciences or a related field
  • 10+ years' experience in Regulatory Affairs within pharmaceuticals and medical devices
  • Experience leading end-to-end product registrations and regulatory strategies
  • Strong people leadership capability
  • Excellent stakeholder engagement skills
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Dallas, TX
5,930 Employees

What We Do

Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Through trusted partnerships with healthcare professionals, we ensure to meet individual consumer and patient needs with superior outcomes.

Similar Jobs

Toast Logo Toast

Software Engineer

Cloud • Fintech • Food • Information Technology • Software • Hospitality
Remote
Canada
5000 Employees
73K-117K Annually

Affirm Logo Affirm

Manager, Machine Learning Engineering (Fraud)

Big Data • Fintech • Mobile • Payments • Financial Services
Easy Apply
Remote
Canada
2200 Employees
178K-228K Annually

Affirm Logo Affirm

Software Engineer

Big Data • Fintech • Mobile • Payments • Financial Services
Easy Apply
Remote
Canada
2200 Employees
142K-210K Annually

Affirm Logo Affirm

Senior Manager, Software Engineering (ML Platform)

Big Data • Fintech • Mobile • Payments • Financial Services
Easy Apply
Remote
Canada
2200 Employees
206K-256K Annually

Similar Companies Hiring

Turion Space Thumbnail
Aerospace • Artificial Intelligence • Hardware • Information Technology • Software • Defense • Manufacturing
Irvine, CA
150 Employees
Fortune Brands Innovations Thumbnail
Manufacturing
Deerfield, IL
2450 Employees
Amalgamated Sugar Thumbnail
Food • Greentech • Agriculture • Industrial • Manufacturing
Boise, Idaho
768 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account