Sr. Manager, Regulatory Affairs CMC

Location
Foster City
Salary
See job description.
Posted
November 18 2020
Ref
R0014872
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Sr. Manager, Regulatory Affairs CMC
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Sr. Manager, Regulatory Affairs CMC

Gilead Sciences is seeking a knowledgeable and motivated professional capable of working effectively in a multi-disciplinary team environment. The successful candidate will assume a full-time employment role in the capacity of Manager in Gilead's CMC Regulatory Affairs department.

Specific Job Responsibilities:
  • Plays a key role in the execution of regulatory affairs CMC strategy for investigational and commercial drugs and combination products.
  • Communicates submission status and regulatory affairs CMC information to internal stakeholders and represents RA CMC on cross-functional project teams.
  • Works cooperatively with regional Gilead regulatory sites to support the accurate and timely communication of critical information.
  • Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational and marketed products for US and global territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • Responsible for submitting moderately complex regulatory documents including amendments, supplements and annual reports to clinical trial applications and marketing authorizations.
  • Works primarily independently with colleagues from regional offices and Affiliates to ensure that CMC dossiers meet US and international standards and to ensure consistency of responses to global Health Authorities.
  • Maintains current knowledge of regulatory requirements and uses industry network to maintain an awareness of the "pulse" of CMC best practices, and to disseminate this information to the internal CMC stakeholders within a global matrixed organization.
  • Primarily plans, schedules and arranges own activities and must be capable of leading a small team in preparation of submissions.
  • Must work well under deadlines and have excellent attention to detail. Strong computer and organizational skills required. Work is performed under limited direction of a senior Regulatory Affairs professional. Excellent verbal and written communication skills and interpersonal skills are required.


Required Education & Experience
  • A Bachelor's Degree in chemistry/manufacturing related scientific discipline and a minimum of eight (8) years of relevant industry experience in Pharmaceutical Regulatory Affairs or closely related field, OR a Master's Degree in chemistry/manufacturing related scientific discipline and a minimum of six (6) years of relevant industry experience in Pharmaceutical Regulatory Affairs or closely related field.
  • Relevant Regulatory CMC submission experience.


Preferred Experience
  • A Regulatory Affairs Certification (RAC)


If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

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.


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.

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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Manager--Regulatory-Affairs-CMC_R0014872-2





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