Senior Manager, Regulatory Affairs CMC

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 CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for

CMC regulatory activities and related regulatory initiatives.

Responsibilities :

Responsible for preparing and / or overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products in line with ICH requirements, regional requirements, and scientific and company policies and procedures

Work collaboratively with cross functional matrix teams to develop a CMC submission plan in accordance with business objectives

Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies

Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear / specific regulatory guidance

Evaluates change proposals for global regulatory impact and plans global amendments

Coordinate and facilitate development of Regulatory CMC strategy with development teams, affiliates for local meetings and interactions

Ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions

Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)

Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner

Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams

Coach and mentor junior regulatory CMC staff

Minimum Qualifications :

Have 8+ years of experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.

Experience with Life Cycle Management

Collaborative, proactive, and highly organized approach to work

Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC Regulatory activities and initiatives

Deep understanding of global regulatory requirements and guidelines

Excellent communication and interpersonal skills

Preferred Qualifications :

Experience in scientific / technical field

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 : $154,020.00 - $199,320.00. 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*.