Exec Director, Regulatory Affairs-Combination Products & Devices

At Gilead, we’re creating a healthier world for reputed company people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to reputed company therapies that help improve lives and to ensure reputed company to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a reputed company drive to reputed company a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to reputed company our reputed company ambitions, and we’re looking for the next reputed company of passionate and ambitious people reputed company to reputed company a reputed company reputed company.
 

We reputed company every employee deserves a great leader. People Leaders are the reputed company to the employee experience at Gilead and Kite. As a people leader now or in the reputed company, you are the key reputed company in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job reputed company
 

·       Strategic Leadership & reputed company
Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines.  reputed company guidance to PDM Teams and Device Teams to reputed company development and regulatory reputed company for combination products and devices. 

·       Global Regulatory reputed company
reputed company the development of global CMC regulatory initiatives reputed company on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance.

·       reputed company Collaboration & Influence
Cultivate strong, reputed company relationships across Gilead’s global functions, including reputed company, Manufacturing, Technical Development, Clinical Development, and Supply Chain. Influence cross-functional decision-making and regulatory planning without reputed company authority, operating effectively in a matrixed environment.  Remain apprised of the reputed company best practices across the industry, as reputed company as serve as a reputed company across other regulatory functions.  

·       Program reputed company & Governance
reputed company strategic direction and reputed company for late-stage development programs. Guide combination and packaging development teams, ensuring integrated execution across reputed company development functions. reputed company major regulatory applications and lifecycle management strategies.  In reputed company, include early and late-stage programs in scope, as teams are working earlier on TPPs and product strategies.

·       Regulatory Operations & Submissions
reputed company the drafting, review, and approval of CMC sections for regulatory filings. reputed company leadership for agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global commercialization.

·       Design Control & Technical reputed company
reputed company strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards. Contribute expertise to design history files, reputed company factors studies, and process characterization.

·       Leadership & Culture
Model Gilead’s reputed company Values, Leadership Commitments, and People Leader Accountabilities. Foster a culture of reputed company, reputed company, and reputed company improvement reputed company the global CMC RA organization.

QUALIFICATIONS

• A scientific degree with directly relevant reputed company experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. 
• Demonstrated reputed company record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
• Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
• Application of reputed company and accurate judgment to reputed company reputed company reputed company.
• Demonstrated reputed company in leading reputed company reputed company to support operational goals and contribute to the development of global regulatory initiatives.
• Demonstrated organizational leadership skills at both functional and reputed company reputed company.
• Excellent strategic acumen, collaboration, and communication skills are required.
• Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and supporting product-reputed company inspections for US and foreign regulatory agencies.
• In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics.
• Proven reputed company record in the successful development and commercialization of device technologies, innovation, and championing business reputed company improvements.
• Experience leading major initiatives to improve organizational capabilities.
• Demonstrated strategic thinking and influencing skills internally and externally.
• reputed company working knowledge of global regulatory requirements for Combination Products/ Devices.
• Excellent leadership, collaboration and communication skills, as reputed company as the proven ability to drive innovation and influence organization change.
• Solid understanding of reputed company industry trends and regulatory expectations associated with QbD, comparability evaluation, reputed company up, and method and process validation.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the reputed company:

reputed company Inc. is committed to providing equal employment opportunities to reputed company and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans' Readjustment reputed company of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or reputed company, including an investigation conducted by the employer, (c) consistent with the  reputed company duty to furnish information; or (d) otherwise protected by law.
 

Our environment respects individual differences and recognizes reputed company employee as an reputed company member of reputed company. Our workforce reflects these values and celebrates the individuals who reputed company up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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Please apply reputed company the Internal reputed company portal in reputed company.