Manager, Regulatory Affairs CMC

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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

Job Description
Manager, CMC Regulatory Sciences

Overview

The Manager of CMC Regulatory Sciences is responsible for authoring analytical related sections of clinical, marketing authorization applications, post-approval variations, renewals for submissions in local and international markets. The Manager also supports

CMC life-cycle management activities.

Essential Duties:

• Author and review analytical related sections of clinical, marketing authorization applications, post-approval variations, for submissions in local and international markets.
• Ensure regulatory submissions are in line with ICH guidance, local statutory requirements, scientific principles, and business policies and procedures.
• Ensure that consistency is maintained across development projects, and that sound scientific justification is employed in CMC regulatory strategy
• Work cross functionally to plan and produce high quality regulatory submissions while meeting aggressive timelines

• Maintains up to date knowledge of regulatory requirements and communicates changes in regulatory information to project teams and senior management in a timely manner
• Contribute to local and/or global process improvements

Knowledge and Skills:

• Excellent verbal and written communication skills and interpersonal skills
• Knowledge of regulatory requirements related to chemistry, manufacturing and control (CMC), including ICH requirements and regional requirements and have an understanding of current global and regional trends in technical regulatory affairs.
• Must be a team player and a self-starter with the ability to work independently.
• Must demonstrate the ability follow corporate procedures and instructions from senior management.

Education and Experience:

• A Bachelor's Degree and a minimum of seven (7) years of experience in Regulatory Affairs CMC or other relevant industry experience OR an advanced degree and a minimum of five (5) years of experience in Regulatory Affairs CMC or other relevant industry experience.
• Advanced degrees including PhD and Masters with a focus on analytical chemistry, chemical engineering, pharmacy/pharmaceutical sciences, or related field is highly desirable
• Must be experienced in authoring technical content of regulatory submissions
• Experience in analytical method development/validation, good manufacturing practices/quality assurance, drug substance or product manufacturing in pharmaceutical industry is highly desirable.

About Gilead

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.

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 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. In 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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 log onto your Internal Career Site to apply for this job.








jeid-3e409413eaee6f439ca4b4e4fd84175c