Shanghai Pharma Biotherapeutics USA, Inc. (SPHBio) is a wholly owned subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. (SPH), 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 Regulatory Operations Specialist

The Senior Regulatory Operations Specialist will support regulatory submission activities related to investigational drug and biologic products. This position will participate in the electronic organization, compilation, publishing, and submission of various regulatory submissions according to timelines and in compliance with established submission standards, including eCTD requirements.

Responsibilities:

• This position will oversee submission planning (including scheduling and resource allocation), formatting, publishing (including QC), transmitting and archiving of regulatory submissions in both paper and/or electronic media to health authorities in the U.S., and possibly EU, Canada, and other global authorities.

• The candidate is expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. Must be able to interpret guidelines and effectively implement them.

• This position may manage internal Regulatory Operations personnel, as well as the activities of external consultants.

• The position will also oversee the development and maintenance of processes, templates, standards, and guidesheets.

• Must be able to oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs.

• This position interacts with Regulatory Affairs and departments providing information to be submitted (including, but not limited to, Clinical, Nonclinical, and Quality).

• Assist the Regulatory Affairs lead in the ompilation and organization of data and documentation for INDs, as well as FDA Meeting Requests and Briefing Documents, IND Amendments, Annual Reports, and General Correspondence

• Generate, review, and format new and revised labeling components for global investigational products

• Monitor, assess, and maintain current awareness of evolving regulations and guidance documents related to Regulatory publishing and submissions

• Review and update standard operating procedures

Required Background:

• Bachelor’s degree from an accredited institution, in a science- or health-related field

• Approximately 5 years of related experience in the CRO, pharmaceutical, or biotechnology industry, with specific experience in the compilation, production and submission of regulatory dossiers in eCTD format

• Strong knowledge of eDMS and eCTD publishing systems. Must have extensive experience with electronic submissions, specifically eCTD.

• Experience with Lorenz DocuBridge submission software system and Sage or Starting Point eCTD document templates

• Excellent software skills using MS Office, Word, Excel, PowerPoint, Adobe Acrobat Pro, and SharePoint/Teams

• Excellent communication (verbal and written) and organizational skills with attention to detail are essential.

• Capable of working independently and in a team environment

• Ability to manage multiple tasks simultaneously

• This position requires the ability to exercise discretion, independent judgment, and clearly identify priorities, as well as to work as needed to meet required timelines.

• Energy and drive to succeed in a high-paced start-up environment

• Regulatory strategy and/or label negotiation experience is a plus