Regulatory Affairs Director Position for Pharmaceutical Leader

5 days ago


Melbourne, Victoria, Australia Gilead Sciences, Inc. Full time
About Us
Gilead Sciences, Inc. is a global biopharmaceutical company dedicated to delivering life-changing medicines to patients with unmet medical needs.

Job Overview
We are seeking an experienced Regulatory Affairs Director to join our team in Australia. The successful candidate will play a key role in leading projects for the Regulatory Affairs team, ensuring compliance with local and international regulations.

Key Responsibilities
The ideal candidate will have extensive experience in regulatory affairs, with a strong understanding of ICH requirements and regional regulations. Key responsibilities will include:
• Developing and implementing complex regulatory strategies
• Managing challenging negotiations with health authorities
• Leading cross-functional project teams
• Ensuring compliance with local laws and regulations
• Maintaining strong relationships with internal stakeholders

Requirements
To be successful in this role, you will need:
• 12+ years of experience in RA or other relevant industry experience
• Strong knowledge of quality assurance, promotional, and non-promotional review as well as pharmacovigilance and market access
• Excellent working knowledge regarding country/national and regional HAs and the local Trade Association
• Excellent communication and interpersonal skills

Gilead Leadership Commitments
We expect all employees to embody our Gilead Leadership Commitments, which include being bold, caring, listening, trusting, and owning their responsibilities. We also commit to diversity and inclusion, fostering a sense of belonging, and achieving career potential.

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