Regulatory Affairs Director

Job Description SummaryProvides 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.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

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

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

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.

Additional Information