Director, CMC Regulatory Affairs – Biologics

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 210,000 - 273,000; Full time

Job summary

Join a forward-thinking biopharmaceutical company as a Director of CMC Regulatory Affairs for Biologics. In this pivotal role, you will define and lead regulatory strategies for innovative therapies aimed at addressing significant health challenges. Your expertise will guide the approval process for critical submissions, ensuring compliance with global standards. Collaborate with cross-functional teams to drive impactful projects and contribute to the development of life-changing medicines. If you are passionate about making a difference and thrive in a dynamic environment, this is the opportunity for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Time Off

Discretionary Annual Bonus

Stock-Based Long-Term Incentives

Qualifications

• 12+ years of experience in biologics development and CMC regulatory affairs.
• Proven track record in executing regulatory strategies.

Responsibilities

• Define regulatory strategy for Biologics portfolio.
• Lead execution of global CMC regulatory plans.

Skills

Biologics Development

Global CMC Regulatory Affairs

Regulatory Strategy Execution

Risk Mitigation Strategies

Advanced Communication Skills

Strategic Acumen

Education

BA/BS in a Scientific Field

MA/MS, PhD, PharmD, or MD

Job description

Director, CMC Regulatory Affairs – Biologics

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 research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

KEY RESPONSIBILITIES

The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions, and “right to operate” by maintaining the global clinical or commercial submissions. In addition, you will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions. As a regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams.

JOB DESCRIPTION

• Lead CMC regulatory strategy for a single or multiple products.
• 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.
• 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.
• Responsible for development of regulatory strategies and solutions for complex CMC challenges for clinical or commercial projects.
• Responsible for interpretation and implementation of ICH and other global guidelines with a goal of an approved/ harmonized regulatory control strategy.
• Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead.
• 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.

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 or 10 years with an MA/MS, PhD, PharmD, or MD.
• Demonstrated track record in executing and implementing CMC regulatory strategies for a given molecule.
• Knowledge of global CMC regulatory landscape.
• Application of sound and accurate judgment to make timely decisions.
• Ability to demonstrate strategic acumen and collaboration.
• Advanced communication and presentation skills.

GILEAD CORE VALUES

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

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 research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

KEY RESPONSIBILITIES

The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions, and “right to operate” by maintaining the global clinical or commercial submissions. In addition, you will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions. As a regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams.

JOB DESCRIPTION

• Lead CMC regulatory strategy for a single or multiple products.
• 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.
• 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.
• Responsible for development of regulatory strategies and solutions for complex CMC challenges for clinical or commercial projects.
• Responsible for interpretation and implementation of ICH and other global guidelines with a goal of an approved/ harmonized regulatory control strategy.
• Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead.
• 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.

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 or 10 years with an MA/MS, PhD, PharmD, or MD.
• Demonstrated track record in executing and implementing CMC regulatory strategies for a given molecule.
• Knowledge of global CMC regulatory landscape.
• Application of sound and accurate judgment to make timely decisions.
• Ability to demonstrate strategic acumen and collaboration.
• Advanced communication and presentation skills.

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: $210,375.00 - $272,250.00. 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*.

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.

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Job Requisition ID R0045156

Full Time/Part Time Full-Time

Job Level Director

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