JOB FUNCTION: Regulatory Affairs
GRADE/TITLE: CMC Regulatory, Director/Senior Director
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: Pharmaceutical Sciences
JOB LOCATION: Beijing, Shanghai
REPORTS TO: Head of Pharmaceutical Sciences, dotted to CMO
SUMMARY: Responsible for working in a fast growing, highly dynamic biotechnology environment, closely interacting with our in-house Regulatory Group, CMC Operations and Quality teams as well as contract manufacturing organizations, external experts and strategic partners. The position will serve to provide a strong Regulatory leadership perspective in support of developing innovative CMC regulatory strategies for drug products in current and future clinical development in China and other markets. The position will also be responsible for hands on management of the collaborative preparation and submission of high‑quality CMC sections of INDs, IMPDs, and NDA. The incumbent will also be involved in additional CMC-related responsibilities, including analytical method development, tech transfer and pharmaceutical development.
DUTIES AND RESPONSIBILITIES:
Developing and implementing regulatory strategies for development projects to achieve optimal submission/approval results and ensure regulatory compliance including filing of all appropriate regulatory submissions for assigned programs.
Coordinating all aspects of regulatory CMC submissions relevant to assigned projects or programs.
Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product lifecycle, to project teams and appropriate management levels within and outside of CMC operations.
Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making.
Identify and assess regulatory risks associated with product development for assigned programs.
Assist in defining strategies to mitigate risks.
Guide the organization and preparation of high-quality submissions to ensure strategic direction and regulatory compliance with the current Guidelines and Regulations are met.
Collecting documentation from other line functions to support submission preparation/
Perform CMC document management tasks including file transfer, storage, tracking, and archival of Regulatory CMC submission documentation to ensure databases are maintained to compliance by collaborating with regulatory affairs and regulatory operations function.
Responsible for leading Agency meetings related to CMC sections.
Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
Degree in life science(e.g. Chemistry, Pharmaceutics, Biochemistry, Biotechnology, Biology) or equivalent.
8+ years in regulatory CMC in biopharmaceuticals/pharmaceutical preferred.
Chinese regulatory experience required.
Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
Knowledge/experience of regulations, guidelines for NCEs and product lifecycle maintenance desirable.
Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
Effective planning, organizational and interpersonal skills.
Reasonable approach to risk assessment.
Excellent written/spoken communication and negotiation skills.
Fluent in English and Chinese (Mandarin).
Timing of relocation to China based on business need.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.