Boehringer Ingelheim Senior Regulatory Affairs Specialist in FREMONT, California
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Senior Regulatory Affairs, Specialist at Boehringer Ingelheim Fremont, Inc. in 6701 Kaiser Drive, Fremont, CA 94555.
Job Duties: Shape the CMC content of regulatory filings in close collaboration with the CMC Project Manager (PM) and other CMC line functions and to drive the implementation of CMC strategy for drug development projects under guidance of the Director CMC Regulatory Affairs; Act as a CMC subject matter expert in project teams for key products and complex/late stage projects; Work cross functionally with scientific/technical experts in biologics development and provide expertise for regulatory guidelines; Work on regulatory submissions for clinical trials and marketing authorizations; Implement CMC work-packages and documentation that meet regulatory expectations at each phase of the development as appropriate; Collaborate closely with CMC PM and other line functions such as Bioprocess & Pharmaceutical Development, Drug Substance and Drug Product Development, Analytical Development, Operations, Quality, Global Tech RA; and Corporate CMC RA to assure that expectations from regulatory agencies are met; Identify critical CMC regulatory issues and implements resolutions in close cooperation with Global Tech RA; Partner with subject matter experts and line management to assess agency requirements and to drive the development of scientifically sound strategies to obtain buy-in from regulatory agencies; Author the Quality Overall Summary as assigned with support of the Director CMC Regulatory Affairs; Support the coordination of the critical review of registration documentation, including INDs and BLAs and performs regulatory assessments of process changes; Prepare regulatory submissions (BLA and IND) and related maintenance documentation (amendments, supplements, annual reports, Dug Master file maintenance, etc.) for US and other Regulatory Health Authorities within defined time schedule; Manage site compliance documents such as GMP certifications and site registration documents; Ensure regulatory submissions are prepared to meet US FDA standards and Regulatory Guidance Checklists; Author regulatory documents and serves as in-house regulatory expert to internal and external parties. Determine regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities. Acts as regulatory liaisons and single point of contact in meetings and interact with members of the project team and sub-teams; and review changes (change control) to manufacturing processes and laboratory methods and specifications to ensure compliance with FDA guidelines and to maintain adequate control and flexibility for the life cycle management of the product.
Job Requirements: Bachelor’sdegree (US or foreign equivalent) in Life Sciences or related field and five(5) years of experience in the job offered or related role in thepharmaceutical industry OR Master’s degree (US or foreign equivalent) in LifeSciences or related field and two (2) years of experience in the job offered orrelated role in the pharmaceutical industry. Prior experience must include eachof the following: CMC regulatory affairs for biological products; working in acGMP environment; knowledge of change control processes; chemistrymanufacturing controls in antibody manufacturing; direct regulatoryauthoring/writing; knowledge and application of FDA regulations and cGMPrequirements; and knowledge of relevant regulatory guidance.
Work Schedule: 40 hours per week (8:00am to 5:00pm)
Organization: US-BI Fremont
Title: Senior Regulatory Affairs Specialist
Requisition ID: 207990