Vacancy expired!
Manager, Regulatory Affairs
Must be local candidate
Manager, Regulatory Affairs CMC Job Responsibilities:
" Plays a key role in the execution of regulatory affairs CMC strategy for investigational and commercial drugs and combination products.
" Communicates submission status and regulatory affairs CMC information to internal stakeholders and represents RA CMC on cross-functional project teams.
" Works cooperatively with regional Gilead regulatory sites to support the accurate and timely communication of critical information.
" Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational and marketed products for US and global 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.
" Works primarily independently with colleagues from regional offices and Affiliates to ensure that CMC dossiers meet US and international standards and to ensure consistency of responses to global Health Authorities.
" 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 internal CMC stakeholders within a global matrixed organization.
" Primarily plans, schedules and arranges own activities and must be capable of leading a small team in preparation of submissions.
" 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. Excellent verbal and written communication skills and interpersonal skills are required.
Required Education & Experience:
Bachelor's degree in chemistry/manufacturing related scientific discipline and minimum of six (6) years of relevant industry experience in Pharmaceutical Regulatory Affairs or closely related field OR a Master's Degree in chemistry/manufacturing related scientific discipline and a minimum of five (5) years of relevant industry experience in Pharmaceutical Regulatory Affairs or closely related field.
Relevant Regulatory CMC submission experience is preferred.
