Senior Manager, Regulatory Affairs China-Cardiopulmonary

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 https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Beijing, China

Job Description:

Summary of Job Responsibilities


* Lead the development of regulatory strategies for Cardiopulmonary TA products, ensuring alignment with overall business objectives.


* Serve as the Regulatory lead to provide strategic regulatory input to China and global compound teams..


* Act as the RA representative to offer regulatory expertise to local and global teams to ensure compliance and strategic alignment.


* Responsible for the execution of CTA and NDA filings and approvals.

Lead the consultations with relevant Health Authorities and address any queries from Health Authorities promptly and effectively.


* Demonstrate keen awareness of Chinese regulatory policies and proactively integrate these insights into the regulatory strategy for applications.

Adapt strategies as needed to align with evolving regulations and guidelines.


* Establish and maintain strong relationships with regulatory authorities and key stakeholders within the local, regional, and global organization to facilitate effective communication and collaboration.


* Ensure that all regulatory activities are conducted with high quality and compliance.

 

Qualifications & Competencies



* Bachelor’s degree or higher in Chemistry, Pharmaceutics, Biology, or a related life-science discipline.


* A minimum of 8 years of regulatory affairs experience within a multinational pharmaceutical company, specifically with expertise in initial New Drug Application (NDA) submissions.


* Strong lobbying and negotiation skills, paired with excellent leadership qualities and a team-oriented spirit.

Highly adaptable with a strong ability to learn and thrive under pressure.


* Exceptional verbal and written English communication skills, with the ability to convey complex regulatory information clearly to diverse audiences.


* Proficient in slide preparation with strong presentation skills.