Senior Research Scientist I, Drug Product Regulatory Strategy

Essential 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 - $215,400.00
Gilead 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 https://www.gilead.com/careers/compensation-benefits-and-wellbeing

For jobs in the United States:
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