Director - Regulatory Affairs Labeling Execution

April 9

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $210.4k - $272.3k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

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Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that has been tackling public health challenges for over 35 years. The company is known for revolutionizing the treatment and prevention of HIV and providing a cure for hepatitis C. With a focus on virology, oncology, and inflammation, Gilead aims to deliver transformative therapies and advance health equity globally. They emphasize scientific innovation to develop next-generation cancer therapies and inclusive clinical trials to address diseases such as HIV. Gilead is also involved in various strategic initiatives and corporate giving programs to support global health and access.

10,000+ employees

Founded 1987

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation. • Regulatory Affairs Labeling Execution plays a key role in providing regulatory strategy and expertise. • Ensures that product labeling and associated documents comply with governing laws, regulations, and company policies. • Collaborates closely with cross-functional partners to ensure compliant and timely delivery of product information labeling. • Lead labeling operations for global and regional labeling documents, including translations and artwork. • Manage error process for labeling, translations and artwork, in collaboration with Quality. • Ensures ongoing awareness of regulatory intelligence related to labeling, translation and artwork activities.

🎯 Requirements

• PharmD/PhD with 6+ years’ relevant experience. • MA/MS/MBA with 10+ years’ relevant experience. • BA/BS with 12+ years’ relevant experience. • 6+ years’ experience in prescription drug labeling. • Extensive experience leading development of end to end labeling process regulatory labeling or related strategies. • Significant experience in global management of drug labeling, including core labeling and regional labeling across U.S., EU, GB, Australia, Canada, Japan, Switzerland, and other markets. • Experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities. • Leadership experience with high complexity, cross-functional initiatives, including team and governance management. • Experience driving inspection readiness and quality processes across the end-to-end labeling process. • Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

🏖️ Benefits

• Company-sponsored medical, dental, vision, and life insurance plans. • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.