Senior Research Scientist I, Drug Product Regulatory Strategy

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: November 23, 2022

Job Description:

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 DescriptionEssential Duties

• Author and review technically complex regulatory CMC submissions in support of clinical and commercial applications. Assure submissions are in line with ICH requirements, global and regional requirements, and scientific and company policies and procedures. Work closely with key stakeholders in Pharmaceutical Development and Manufacturing to produce high-quality submissions while meeting aggressive timelines.
• Support the definition and implementation of ICH Quality by Design (QbD) approaches relevant to control strategy development, risk analysis, and lifecycle management.
• Guide stakeholders in the successful implementation of relevant regional regulatory agency guidelines (e.g., 21 CFR Part 4, ISO, EMA MDR) for development and registration of complex package configurations, devices, and combination products.
• Maintain up-to-date knowledge of regulatory requirements and communicate changes in regulatory information to project teams and senior management in a timely manner. Initiate and/or support local process improvements and contribute to global process improvements.
• Track responses and other interactions with regulatory agencies and provide relevant guidance to development teams. Assist in maintaining a knowledge base of agency interactions. Participate in responses to regulatory agencies.
• Review technical reports and other documents related to development studies and help to ensure consistent documentation practices. Assist development teams with documentation strategies. Maintain / track relevant report metrics.Knowledge and Experience
  • A BS degree in a relevant discipline and minimum 10 years of relevant pharmaceutical industry experience are required. An advanced degree and technical background are preferred.
  • Excellent verbal and written communication skills and interpersonal skills are required. Previous technical writing experience in a professional setting and/or a documented publication history are preferred.
  • Must be a team player and a self-starter with the ability to work with minimal direction. Work is performed with no immediate guidance from Regulatory Affairs professionals.
  • A working knowledge of global and regional regulatory requirements and an understanding of current global and regional trends in Regulatory Affairs are required. Is recognized as a knowledgeable resource for guidance in specific regulatory matters impacting drug product, packaging, device, and combination product control strategy development and documentation.
  • Knowledge of technical development requirements for multiple types of dosage forms, packages, and devices is desirable. Previous experience in drug product formulation and process development and combination product development are preferred.For Colorado Job Applicants: The salary range for this position is:$143,600.00 - $215,400.00Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary. Position is also eligible for bonus and benefits. For more information, visit 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.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. 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.
    
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Keywords: Gilead Sciences, Inc., San Mateo , Senior Research Scientist I, Drug Product Regulatory Strategy, Other , San Mateo, California