Responsible for the execution of regulatory affairs CMC strategy for investigational and commercial drugs. Communicate submission status and regulatory affairs CMC information to internal stakeholders. Works cooperatively with all regional regulatory sites to support the accurate and timely communication of critical information. Monitor and enter information from a variety of regulatory and change control systems to capture regional regulatory assessments of the change. Must work well under deadlines and have excellent attention to detail. Strong computer and organizational skills required. Work is performed under limited direction of a senior Regulatory Affairs professional.
Responsible for the preparation of regulatory submissions, including those that may be considered moderately complex, which require interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for submitting moderately complex regulatory documents including amendments, supplements and annual reports to clinical trial applications and marketing authorizations original INDs and NDAs.
Under the general direction of a senior Regulatory Affairs professional, preparing investigational, new drug applications, and post approval submissions for US
Primarily independently works with colleagues in all regions to ensure that CMC dossiers meet international standards.
Work with international colleagues to ensure consistency of responses to international Health Authorities.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.
As appropriate, provide support for cGMP activities as they relate to regulatory affairs: PAI, maintenance of local manufacturing license, etc.
Work with PDM and other Gilead sites to maintain a high level of cooperation and communication on CMC Regulatory Affairs issues.
May participate as project team representative for specified products depending upon the complexity of the project.
Maintains current knowledge of regulatory requirements and uses industry network to maintain an awareness of the "pulse" of CMC best practices, and to disseminate this information to the CMC regulatory affairs Contributes to local and/or global process improvements, which have a significant impact for the Regulatory Affairs CMC Department.
Work cross-functionally within a matrixed organization
May contribute to the training of staff under the direction of a senior Regulatory Affairs professional. Primarily plans, schedules and arranges own activities and may direct others in accomplishing objectives.
Excellent verbal and written communication skills and Interpersonal skills are required.
Negotiation skills a plus.
Requires a Bachelor's degree and minimum of 6 years of relevant experience in Regulatory Affairs or related field preferably in a GMP environment
Excellent organizational skills and ability to work on a number of projects with tight timeline is required. Excellent verbal and written communication skills and interpersonal skills are required.
Must be knowledgeable of regulatory requirements, including ICH requirements and US regional requirements
Must be capable of leading a small team in preparation of submissions.
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 firstname.lastname@example.org assistance.
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