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Senior Director/Vice President, Regulatory Affairs & Quality

Status: Archived
CompanySphBio
LocationSan Diego, CA
Expiration2021-12-01
How to Apply

Send resume to licj@sphchina.com

Shanghai Pharma Biotherapeutics USA Inc. (SPHBio; www.sphbio.com) is a wholly owned subsidiary of Shanghai Pharmaceuticals Holding Co. Ltd. (SPH; www.sphchina.com), one of the largest pharmaceutical companies in China. SPH has developed and delivered healthcare solutions and effective medicines to patients in China for the past century.  SPH is committed to continuously bringing innovative medicines to patients that alleviate or cure diseases.  SPHBio’s mission is to work with researchers, collaborators, and investors to identify and advance biopharmaceutical innovations that address unmet medical needs.
Senior Director/Vice President, Regulatory Affairs & Quality
The Senior Director/Vice President, Regulatory Affairs & Quality is responsible for developing, implementing, and leading both regional and international strategy, while also acting as the Company's regulatory representative. This role oversees the execution of regulatory strategies for the Company’s regulatory applications at all stages of development. The Senior Director/Vice President provides guidance for, and actively contributes to, the development of documents (e.g., INDs/IMPDs/CTAs, NDAs/BLAs/MAAs) for regulatory agencies to ensure that they meet current regulatory requirements and industry standards.
Job Location: San Diego, CA

Responsibilities:
Develop and execute regional and international strategies
Provide efficient and effective Regulatory representation across the organization and act as a key figure in interactions with the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies
Lead the preparation of submissions, which include INDs, briefing documents, orphan drug applications, and NDAs/BLAs/MAAs, etc.
Serve as a primary interface for FDA, EMA, and other regulatory agencies
Maintain knowledge of the global competitive landscape, regulatory environment, regulations and guidelines
Contribute to the development and maintenance of the Regulatory and Quality working practices and procedures
Manage staff and vendors as needed to support regulatory activities
Required Background:
Bachelor’s degree from an accredited institution, in a science- or health-related field
10 - 15 years of regulatory experience in the CRO, pharmaceutical, or biotechnology industry
5+ years supervisory/management experience
Demonstrated experience interacting with regulatory agencies
Demonstrated leadership experience in the establishment of INDs and approvals of NDAs/BLAs/MAAs
Clear understanding of the drug development process with experience in multiple phases in various therapeutic areas
Experience in preparations of regulatory CMC filings a huge plus
Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
Results-oriented with a keen attention to detail
Energy and drive to succeed in a high-paced start-up environment
 

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