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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Beijing, ChinaJob 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.
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