Senior Director, CMC Regulatory Affairs – Biologics Project Lead

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make 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 achieve our bold ambitions, and we’re 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

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

About the Role :

The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix team of professionals, who work with a specific product in Gilead’s global portfolio of biological products in CMC Regulatory Affairs.

This position will provide leadership at a product level as a global lead that ensures right first time global approvals of CMC regulatory (Biologics) submissions, and right to operate by maintaining the global licensures.

In addition, the Sr Director will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.

The leader will also be responsible for

ensuring the projects they are responsible for have a cohesive regulatory

strategy that is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs Biologics at Gilead.

Specific Responsibilities and Skills

Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.

Implement global CMC regulatory strategies to enable life-cycle product / process development strategy while maintaining global licensure and right to operate of Gilead’s operations.

Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.

Guide the development of regulatory strategies and solutions for complex CMC challenges

for Clinical through Growth (newly approved) products submission, commercial registration, including risk mitigation.

Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved / harmonized regulatory control strategy.

Ensure regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures.

Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead.

Promote the use of novel approaches within project teams to resolve issues and problems.

Develop meaningful and collaborative relationships with cross-functional teams and leaders.

Lead CMC strategies, assess risks, and develop contingency plans, including major, complex applications.

Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.

Demonstrate success in influencing without positional authority within a highly matrixed organization.

Minimum Qualifications :

A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA / BS or10 years with an MA / MS, PhD, PharmD, or MD.

Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.

Experience with leading NDA / BLA submission and approvals including global Health Authority Interactions.

Application of sound and accurate judgment to make timely decisions.

Demonstrated organizational leadership skills at a functional level.

Excellent strategic acumen, collaboration, and communication skills are required.

Demonstrated commitment to inclusion, developing talent and empowering teams.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

The salary range for this position is : $237,660.00 - $307,560.00. 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*.