(Senior) Principal Scientist, CMC Regulatory Affairs - Biological

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Regulatory Science

Job Category:

Scientific/Technology

All Job Posting Locations:

Beijing, China, Shanghai, China

Job Description:

• The primary responsibility of the CMC Regulatory Affairs Principal Scientist is to provide CMC regulatory supports for the submissions in China with a current focus on antibody products (e.g. monoclonal, bispecific antibody and antibody-drug conjugates) CMC studies and BLA preparation.  He/she will also support biological product filings across multiple registration categories in China.  He/she will be involved in communication with global CMC RA and DPDS functions to ensure adequate support for the registration testing at NIFDC or PFDA Laboratories.  He/she will be involved in communication with global CMC RA and GRA China product leads to ensure adequate supports for the challenges in drug registration. He/she should support China CMC RA Lead to build a closer connection with NMPA and influence the local regulatory environment.  He/she will participate in RDPAC task forces and activities and comment on NMPA new regulations.
• Responsibilities may eventually expand to include a role to provide timely regulatory risk assessment due to various CMC variations along with GRA China product leads to products marketed in China. Based on a broad regulatory and technical expertise, he/she will also provide guidance to local, regional and/or global associates, ensuring that CMC regulatory and development strategies are consistent with evolving expectations of NMPA.

 

 

Required Skills:

 

 

Preferred Skills:

Consulting, Corporate Governance, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Mentorship, Public Policies, Regulatory Compliance, Regulatory Development, Regulatory Environment, Scientific Research, Strategic Thinking, Subject Matter Experts (SME) Collaboration, Tactical Planning, Technical Credibility, Technical Writing