Sr. Regulatory Affairs Associate, Liaison (Oncology)

15 Aug, 2021

Jobs

Sr. Regulatory Affairs Associate, Liaison (Oncology)

Gilead Sciences
Foster City, CA/Seattle, WA

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

Great opportunity in the growing Oncology team at Gilead.  Opportunity to be a regional regulatory strategist in the growing Trodelvy franchise as well as work on programs across the oncology area.  Work with talented cross functional teams on this exciting compound that is the key driver for Gilead Oncology in the future.

**This role can be based out of Foster City, CA or Seattle, WA office. **

  • May lead designated regional regulatory activities of the Regulatory Project Team.
  • Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
  • May participate on other sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers teams).
  • Responsible for preparing moderately complex regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • May provide input to the content of the original label (region specific).
  • May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories (region specific).
  • Responsible for development and acquisition of required regulatory skills and knowledge, under guidance of immediate manager.
  • May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments.
  • Participates in group meetings and presents project status updates and strategic approaches to moderately complex programs/projects.
  • Is recognized as a knowledgeable resource within the department on limited topics.
  • Work is performed under minimal supervision of a Regulatory Affairs professional.

Knowledge & Skills:

  • Strong organizational skills and ability to work on several projects in alignment with timelines.
  • Strong verbal and written communication skills and interpersonal skills.
  • General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
  • Is recognized as a knowledgeable resource within the department on limited topics.
  • Work is performed under minimal supervision of a Regulatory Affairs professional.

Education, Skills & Experience:

  • 5+ years of relevant training or industry experience with BS/BA.
  • 3+ years of relevant training or industry experience with advanced degree.
  • Degree in a scientific field is preferred.
  • Strong organizational skills and ability to work on several projects in alignment with timelines.
  • Strong verbal and written communication skills and interpersonal skills.
  • General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.

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.

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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.

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.

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Job posted: 2021-08-15