Head of Regulatory Affairs - ANZ page is loaded Head of Regulatory Affairs - ANZ Apply locations North Sydney time type Full time posted on Posted Yesterday job requisition id JR005406

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, 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're 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.

We are seeking an experienced Head of Regulatory Affairs to join our team in Australia and New Zealand. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our pharmaceutical products in these markets. This is a senior leadership role that will provide strategic direction and guidance to our regulatory affairs team.

Key Responsibilities
• Develop and implement regulatory strategies and policies that support Galderma's business goals and objectives in Australia and New Zealand.
• Manage a team of regulatory affairs professionals, providing guidance and leadership on regulatory issues and ensuring compliance with regulatory requirements.
• Liaise with regulatory agencies and industry bodies to maintain a strong understanding of regulatory requirements and changes that may impact the business.
• Ensure that all product submissions and regulatory filings are accurate, complete, and submitted on time.
• Conduct regulatory assessments of new products or changes to existing products, and provide guidance on compliance issues.
• Develop and maintain strong relationships with internal stakeholders, including R&D, commercial, and legal teams.
• Represent Galderma at regulatory meetings and conferences, and stay up-to-date with industry trends and best practices.

Skills & Qualifications
• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• At least 10 years of experience in regulatory affairs for pharmaceutical products, with a strong understanding of regulatory frameworks in Australia and New Zealand.
• Experience leading a team of regulatory affairs professionals, providing guidance and leadership on regulatory issues.
• Strong understanding of drug development processes and clinical trial requirements.
• Excellent communication and leadership skills, with the ability to influence and persuade internal and external stakeholders.
• Proven track record of success in managing regulatory affairs for pharmaceutical / consumer products.

What we offer in return

You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Next Steps
• If your application is successful and your profile is a match, our recruiter will reach out to you directly and engage you in the first conversation regarding this role.
• The next step is a virtual conversation with the hiring manager.
• The final step is a panel conversation with the extended team face to face.

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 is the perfect environment for people to thrive and excel in what they do.
About us

Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we're in shapes our life stories, we are advancing dermatology for every skin story.

For more information, please visit our website
Sydney NSW Australia

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