Reg Affairs Assoc II

Location
Foster City
Salary
See job description.
Posted
November 18 2020
Ref
R0015737
Position Type
Full Time
Organization Type
Pharma
Job Type
Other


Reg Affairs Assoc II
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


Responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.

  • Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.
  • Responsible for development and acquisition of required regulatory skills and knowledge, with manager support.
  • May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
  • Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department
  • Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
  • Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
  • Seeks assistance from appropriate internal and external resources.


Knowledge and Skills
  • Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.
  • Strong verbal and written communication skills and interpersonal skills.
  • Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
  • Proficiency in Microsoft Word and Excel.
  • Experience with Microsoft Power Point, Project and Visio a plus.
  • Act as a resource on limited topics within the department.
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.


Education and Experience
  • 4+ years of relevant training or industry experience with BS/BA.
  • 2+ years relevant training or industry experience with advanced degree.
  • Degree in a scientific field is preferred.

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/Reg-Affairs-Assoc-II_R0015737-1





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