Sr. Regulatory Ops Associate

Morris Plains, NJ, United States
Jun 02, 2021
Required Education
Bachelors Degree
Position Type
Full time
Sr. Regulatory Ops Associate
United States - New Jersey - Morris Plains

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. Gilead's 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 company's five core values. That's 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 formatting and publishing electronic documents, and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time. The position will also archive and track regulatory correspondence, documents and submissions.
  • Electronically format and publish electronic documents; builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
  • Provides guidance on good documentation and submission practices to project teams.
  • Coordinates submission timelines and content plans.
  • Archive (categorizing and classifying information) all Regulatory records pertaining to multiple Regulatory Applications (e.g., IND, BLA, CTA), maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed.
  • Identifies and communicates regulatory system enhancement needs or technical issues.
  • Assists with regulatory inspection activities.
  • Maintains Document Authoring Template Library and Template development.


  • BS/ BA with minimum 5 years or MA/ MS with 3 years of experience in Regulatory Operations with submissions responsibility.
  • Strong familiarity with applicable FDA, EU and ICH guidelines related to regulatory submissions, clinical trials and marketing applications.
  • Working knowledge of eCTD publishing systems, EDMS technology (Veeva Vault preferred), and authoring tools and templates (Starting Point preferred).
  • Clear understanding of regulatory submission content and format requirements.
  • Good understanding of applicable FDA and ICH guidelines related to regulatory submissions.
  • Good understanding of eCTD publishing systems, EDMS technology (Veeva Vault preferred) and authoring tools and templates (StartingPoint preferred).
  • Clear understanding of regulatory submission content and format requirements.
  • Experienced in lifecycle management eCTD submissions including but not limited to, IND Safety, and IND Investigator submissions.
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has effective written and verbal communication skills.
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 for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.



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:
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