Director of Analytical Regulatory Sciences
6 days ago
Gilead Sciences, Inc. is a leading biopharmaceutical company dedicated to creating innovative treatments for complex diseases. We are seeking a highly skilled and experienced professional to join our team as an Associate Director, Analytical Regulatory Sciences.
Key Responsibilities:
- Collaborate with cross-functional teams to develop and implement analytical control strategies for regulatory submissions.
- Interpret and implement ICH and regional guidelines to ensure right-first-time approval of regulatory control strategies.
- Evaluate and implement new regulatory and quality requirements for analytical control strategies in partnership with technical and manufacturing teams.
- Develop and maintain relationships with health authorities and regulatory agencies to ensure compliance with regulatory requirements.
- Lead and participate in business process development initiatives to improve quality compliance and regulatory filing content.
Requirements:
- Bachelor's degree in a relevant field and 10+ years of experience in analytical regulatory sciences or a related field.
- Master's degree in a relevant field and 8+ years of experience in analytical regulatory sciences or a related field.
- PhD in a relevant field and 2+ years of experience in analytical regulatory sciences or a related field.
What We Offer:
- Competitive salary range: $177,000 - $230,000.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time off and a comprehensive benefits package.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is an equal opportunity employer committed to a diverse workforce. We are dedicated to creating a workplace that is inclusive and respectful of all employees, regardless of their background, culture, or identity.
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