- (Boston)

Job Responsibilities :

Establish Pharmaceutical Development Plan (PDP) and Chemical, Manufacture and Controls (CMC) regulatory strategy according to the clinical development progress (CDP), ensure that pharmaceutical development and regulatory filings are aligned with the requirements of clinical development and marketing authorization application, and effectively organize and coordinate resources to guarantee the timeline of each regulatory activities.

CRO

Oversee the overall progress of projects, coordinate internal teams (including R&D, manufacturing, quality, and clinical teams) and external entities such as CROs, ensure the timely and compliant preparation of regulatory filing documents, monitor project risks (e.g., policy updates, updates to technical requirements), promptly adjust strategies, and facilitate the smooth progression of the regulatory registration process.

Prepare the registration dossier to ensure that the contents comply with the requirements of regulations and guidelines. Review the technical doc and data provided by CMC R & D, production and other departments to ensure data integrity, scientific and compliance.

Responsible for Agency communications, including timely response to queries or supplementary information required from regulatory authorities, and organizing CMC related meetings with Agency.

NMPAFDAEMA

Track the updates of policies, guidelines (e.g., NMPA, FDA, EMA, etc.), as well as product-related technical literature and patents, collate and interpret the report to provide reference for the CMC R&D and RA team.

Good English writing and oral communication skills as the working language.

Master or PhD, PhD preferred; major in Chemistry, Biology, Pharmacy, etc.

Understand the drug application procedure, being familiar with pharmaceuticals regulations is preferred.

Possess strong English listening, speaking, reading and writing skills, with English serving as a working language.

OfficeWord / Excel / PPTPDF Adobe Acrobat

Documentation and review capability, proficient in Office (Word / Excel / PPT), PDF editing tools (e.g., Adobe Acrobat).

Exhibit advanced learning agility, enabling the rapid absorption of complex industry technical demands and the ability to anticipate regulatory policy trends, thereby adjusting long-term work strategies to align with organizational and regulatory objectives.

Be detail-focused and rigorous in work execution, maintain heightened sensitivity to data and document accuracy, and take effective measures to minimize compliance risks related to application dossiers.

Good communication and coordination skills, able to effectively dock internal and external teams, and promote problem solving.

deadlines

Responsible, able to withstand certain deadlines pressure of the project, and have a sense of teamwork.

Possess a clear career roadmap and is dedicated to long-term professional growth within the domain of regulatory registration and compliance.