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Senior CMC Regulatory Affairs Manager

2 months ago

Foster City, United States Gilead Sciences Full time

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we are dedicated to fostering a healthier world for everyone.

With over 35 years of experience, we have addressed diseases such as HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to develop therapies that enhance lives and ensure their accessibility worldwide.

Our commitment to combating the most significant health challenges necessitates collaboration, determination, and an unwavering drive to effect change.

Every member of Gilead's team is crucial in the discovery and development of transformative scientific innovations.

Our workforce is our most valuable asset as we strive to realize our ambitious goals, and we seek passionate and driven individuals ready to make a tangible impact.

We believe that every employee deserves an exceptional leader. People Leaders are fundamental to the employee experience at Gilead and Kite.

As a people leader, whether now or in the future, you will be instrumental in evolving our culture and fostering an environment where every employee feels included, developed, and empowered to achieve their aspirations.

Join Gilead and collaborate to create possibilities.
Job DescriptionGilead Sciences, Inc.

is a biopharmaceutical organization that has achieved significant breakthroughs in medicine for over three decades, aiming to create a healthier world for all.

The company is devoted to advancing innovative treatments to prevent and manage life-threatening diseases, including HIV, viral hepatitis, and cancer.

Gilead operates in over 35 countries globally, with its headquarters in Foster City, California.
About the role:
The Senior Manager of CMC Regulatory Affairs at Gilead is tasked with providing strategic guidance, operational support, and technical expertise for CMC regulatory activities and associated regulatory initiatives.
Responsibilities:
Responsible for preparing and/or overseeing the preparation of intricate regulatory CMC submissions for investigational and commercial products in alignment with ICH requirements, regional mandates, and scientific and corporate policies and procedures.
Work collaboratively with cross-functional matrix teams to devise a CMC submission strategy in accordance with business objectives.
Actively engage with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality), external partners, and CROs to formulate and implement robust CMC regulatory strategies.
Provide regulatory counsel, making informed decisions on regulatory matters where clear/specific guidance may be lacking.
Assess change proposals for global regulatory implications and plan global amendments.
Coordinate and facilitate the development of Regulatory CMC strategy with development teams and affiliates for local meetings and interactions.
Maintain current knowledge of CMC regulatory intelligence, including guidelines and regulatory trends, and drive and implement strategic policy decisions.
Lead interactions with FDA and other Health Authorities on CMC-related issues (including management of regulatory deliverables and commitments).

Ensure project teams, line management, and key stakeholders are informed of developments that may affect regulatory success, exercising sound judgment and communicating in a professional and timely manner.
Initiate process enhancements and contribute to global process improvements that significantly impact the Regulatory Affairs CMC Department or development matrix teams.
Mentor and coach junior regulatory CMC staff.
Minimum Qualifications:
8+ years of experience in Regulatory Affairs CMC or other relevant industry experience with an advanced degree.

Experience with Life Cycle Management.
A collaborative, proactive, and highly organized approach to work.
A proven track record in strategic planning, problem-solving, and functioning within a global matrix team environment, successfully managing CMC Regulatory activities and initiatives.
A deep understanding of global regulatory requirements and guidelines.
Excellent communication and interpersonal skills.
Preferred Qualifications:
Experience in a 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: $154,000 - $199,000. Gilead considers various 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:

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

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.

Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic 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 laws.

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 assistance.

For more information about equal employment opportunity protections, please view the 'Know 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 opinions.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Summary Location:
United States - California - Foster City Type: Full time