Senior Regulatory Affairs Manager

Galderma; North Sydney Council; Hybrid; AUD 130,000 - 160,000; Full time

Benefits offered by this job

Career development opportunities

Paid parental leave

Birthday leave

Flexible hybrid work policy

Dermatology treatments twice a year

Generous product discounts

Job summary

A leading dermatology company is seeking a Senior Regulatory Affairs Manager for its Sydney office. This role involves strategic oversight for regulatory operations across Australia and New Zealand, ensuring compliance and timely submissions for pharmaceuticals and medical devices. Candidates should possess a degree in Pharmacy or Life Sciences, have over 10 years of regulatory experience, and demonstrate strong leadership and stakeholder engagement skills. The position offers career development and various employee benefits, including flexible working arrangements.

Qualifications

• 10+ years' experience in Regulatory Affairs within pharmaceuticals and medical devices.
• Proven experience leading product registrations and regulatory strategy in Australia and New Zealand.
• Strong people leadership capability, managing small teams.

Responsibilities

• Provide strategic regulatory leadership to the ANZ Country Leadership Team.
• Lead end‑to‑end regulatory submissions and lifecycle maintenance.
• Manage local regulatory operations, ensuring compliance with TGA and Medsafe.

Skills

Regulatory Affairs

Stakeholder engagement

Leadership

Education

Bachelor's degree in Pharmacy, Life Sciences or related field

Master's degree (desirable)

Job description

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 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

• 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