Director of Regulatory Affairs San Jose, CA REF

Director of Regulatory Affairs Location:

San Jose, CA DESCRIPTION

The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) and for covering multiple development projects. Requirements

Develop and execute regulatory strategies for earliest possible approvals for development programs. Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams. Set strategy for submissions of product registration documents to health authorities worldwide. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions. Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA and other submission documents including meeting packages, briefing documents, responses, supplements etc. Experience in CMC regulatory compliance to ensure CMC practices are carried out in agreement with regulatory agencies requirements and expectations. Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites. Interact with regulatory agencies on defined matters. Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests. Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable. Interface with international affiliates on regional regulatory strategy and implementation of plans. Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines. Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures. EDUCATION AND/OR JOB EXPERIENCE

Bachelor’s or Master’s degree in a scientific discipline. 10-15 years’ experience in Regulatory Affairs in biotechnology & pharmaceutical industry. Thorough knowledge of the drug, device and combination product development process with demonstrated experience in developing global regulatory strategy and submissions. Experience in multiple phases of development in various therapeutic areas is desirable. Experience with biologics is a must. Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously. Ability to communicate and interact effectively across departments and on project team(s). Results driven and team-orientated, with the ability to influence outcomes. Ability to travel.

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