GE HealthCare Associate Director Regulatory Affairs 

China, Guangdong Province, Yuexiu District 

749863279

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

Primary Responsibilities:

• Develop regulatory strategies for innovative drugs in China, including the submission of IND (Investigational New Drug) and NDA (New Drug Application).
• Work closely with healthcare regulatory bodies in China to ensure compliance with premarket and post-market regulatory requirements.
• Develop relationships with Chinese Regulatory agencies (NMPA, CDE, NIFDC, Ch.P. etc.) and responsible for communication with regulatory authorities regarding new drugs, including Pre-IND, End of Phase II/Phase III, and Pre-NDA meetings.
• Utilize in-depth regulatory knowledge and analytical thinking to execute policies and strategies.
• Lead a small team, mentor colleagues with less experience, and drive consensus within the team on relevant topics.
• Stay informed about new policies and requirements, and assess their impact on business and regulatory strategies, insure to follow company processes and quality management system.
• Propose different solutions to address more complicated day-to-day problems, prioritize information for data analysis.
• Communicate and collaborate effectively with cross-departmental teams (e.g., R&D, business, sales) and international colleagues at headquarters.

Required Qualifications:

• Bachelor's degree or above in pharmacy, medicine, biology, or related fields.
• At least 10-15 years of regulatory experience in the pharmaceutical industry, including 3+ years in the field of nuclear medicine, particularly innovative drugs.
• People management experiences.
• Strong oral and written communication skills internal/external, local/global
• Effective communication and collaboration with local and global regulatory, quality and R&D teams

Desired Characteristics:

• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, execute regulatory programs.
• Stablished NCE IND and NDA projects management skills.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.