Global Regulatory Affairs Lead
2 months ago
Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Director of Global Regulatory Affairs for Precision Medicine to play a pivotal role in shaping the regulatory landscape for our innovative therapies.
This position demands a deep understanding of global regulatory requirements, particularly within the dynamic field of precision medicine. You will be responsible for developing and executing comprehensive regulatory strategies that align with Gilead's overall business objectives.
Responsibilities:- Serve as a subject matter expert on precision medicine within cross-functional teams, providing strategic guidance on biomarker development and clinical trial design.
- Lead the development and implementation of global regulatory strategies for precision medicine products, ensuring compliance with international health authority guidelines.
- Maintain a thorough understanding of evolving regulations governing in vitro diagnostics (IVDs) and their impact on precision medicine applications.
- Provide expert regulatory input throughout the clinical development process, collaborating closely with research and development teams to ensure seamless regulatory submissions.
- Spearhead the preparation and filing of comprehensive Health Authority (HA) briefing books, effectively communicating scientific data and regulatory rationale to global health authorities.
- Cultivate strong relationships with key stakeholders within Gilead and external partners, fostering a collaborative environment that drives scientific advancement in precision medicine.
- Contribute to process improvements within the regulatory affairs function, enhancing efficiency and effectiveness across all areas of precision medicine development.
- Lead training initiatives for internal teams on evolving regulatory requirements and best practices related to precision medicine.
- Ensure unwavering adherence to all applicable regulatory requirements, safeguarding Gilead's reputation and commitment to ethical conduct.
- Represent Gilead at prominent industry conferences and meetings, showcasing our expertise in precision medicine and engaging with global thought leaders.
A Bachelor's or advanced degree in a life sciences discipline is essential, coupled with significant experience in regulatory affairs within the pharmaceutical or biotechnology industry. A strong understanding of global regulatory requirements, health authorities, and analytical skills are crucial for success in this role. The ideal candidate possesses exceptional communication, interpersonal, and leadership abilities, thriving in a fast-paced, collaborative environment.
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Global Regulatory Affairs Leader
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Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeJob SummaryGilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Regulatory Affairs Business Operations team. As the Global Regulatory Affairs Business Operations Lead, you will be responsible for developing and implementing global regulatory affairs infrastructure, compliance, process, and capability development.Key...
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Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeJob Description:Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Regulatory Affairs Business Operations team. As the Global Regulatory Affairs Business Operations Lead, you will be responsible for developing and implementing global regulatory affairs infrastructure, compliance, process, and capability development.Key...
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Global Regulatory Affairs Director
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Global Regulatory Affairs Leader
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Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Title: Executive Director, Regulatory Affairs LabelingAbout the Role:Gilead Sciences International, Ltd. is seeking an experienced Executive Director to lead our Regulatory Affairs Labeling function. As a key member of our Global Regulatory Affairs organization, you will be responsible for creating, updating, and maintaining product information and...
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Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Title: Global Regulatory Affairs Labeling DirectorJob Summary:Gilead Sciences International, Ltd. is seeking a highly experienced Global Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling organization. The successful candidate will be responsible for developing and implementing global labeling strategies, ensuring...
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Regulatory Affairs Lead
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Regulatory Affairs Lead
2 months ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeGilead Sciences International, Ltd. is seeking a highly motivated and experienced Regulatory Affairs professional to join our global team as an Associate Director, Regulatory Affairs CMC. In this role, you will be responsible for leading the regulatory strategy and submissions for Kite's existing commercial and/or clinical programs within the EU region. You...
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