Exec Director, Regulatory Affairs-Combination Products & Devices
Exec Director, Regulatory Affairs-Combination Products & Devices
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$ 274550 - 355300
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver 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 Description
Strategic Leadership & Vision
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. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices.
Global Regulatory Excellence
Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets maintaining compliance with evolving health authority requirements and internal governance.
Enterprise Collaboration & Influence
Cultivate strong collaborative relationships across Gileads global functions including Quality Manufacturing Technical Development Clinical Development and Supply Chain. Influence cross-functional decision-making and regulatory planning without direct authority operating effectively in a matrixed environment. Remain apprised of the current best practices across the industry as well as serve as a liaison across other regulatory functions.
Program Oversight & Governance
Provide strategic direction and oversight for late-stage development programs. Guide combination and packaging development teams ensuring integrated execution across all development functions. Lead major regulatory applications and lifecycle management strategies. In addition include early and late-stage programs in scope as teams are working earlier on TPPs and product strategies.
Regulatory Operations & Submissions
Oversee the drafting review and approval of CMC sections for regulatory filings. Provide leadership for agency interactions inspections and regulatory responses. Ensure readiness and compliance for global commercialization.
Design Control & Technical Strategy
Provide 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 human factors studies and process characterization.
Leadership & Culture
Model Gileads Core Values Leadership Commitments and People Leader Accountabilities. Foster a culture of integrity excellence and continuous improvement within the global CMC RA organization.
QUALIFICATIONS
- A scientific degree with directly relevant professional 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 track 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 sound and accurate judgment to make timely decisions.
- Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
- Demonstrated organizational leadership skills at both functional and enterprise levels.
- Excellent strategic acumen collaboration and communication skills are required.
- Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and supporting product-related 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 track record in the successful development and commercialization of device technologies innovation and championing business practice improvements.
- Experience leading major initiatives to improve organizational capabilities.
- Demonstrated strategic thinking and influencing skills internally and externally.
- Sound working knowledge of global regulatory requirements for Combination Products/ Devices.
- Excellent leadership collaboration and communication skills as well as the proven ability to drive innovation and influence organization change.
- Solid understanding of current industry trends and regulatory expectations associated with QbD comparability evaluation scale up and method and process validation.
The salary range for this position is:
Gilead considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.
For additional benefits information visit:
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make 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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Director
Employment Type
Full-Time
