Location(s): United States, United Kingdom; Massachusetts; Marlborough, Amersham
About Us: GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.
Learn More About Careers at GE Healthcare – Life Sciences GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. 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.
Role Summary: The Global Head of Regulatory Strategy leads the Global Regulatory Strategy function within GEHC Life Sciences Core Imaging business and ensures that resources are appropriately deployed and global regulatory strategies are optimized and aligned with business needs.
Leads the Global Regulatory Strategy) Team, ensuring that the GRL Global Regulatory Lead) resource provides high quality, strategic advice and is seen as a valued strategic partner across the organization and builds effective relationships with major regulatory agencies
Ensures delivery of major new product filings and that lifecycle registration and compliance commitments are met
Determines clear priorities for the GRL Team and communicates those to the business so that expectations are appropriately managed
Owns a portfolio of regulatory delivery projects (up to 40% of available time)
Participates as a full and active member of the Regulatory Affairs Leadership Team, other key function working parties and key decision making bodies within GE Healthcare (e.g. portfolio Committee and Phase Review Discipline) and acts as delegate for Global Head of Regulatory Affairs as appropriate
Ensures effective strategies are in place for attraction, retention and succession planning for the GRS Team
Implementation and management of effective resource allocation processes within the GRS team and deployment of external support to meet business demands
Supports and encourages a collaborative, open and team based cultures across the global function
Engenders close and effective working relationships with regional Regulatory and RISM (Regulatory Information and Submission Management) colleagues and actively resolves areas of conflicts or sub optimal operation
Ensures that function systems and supporting processes are adequate for effective GRS Team operation and that an ongoing process improvement mind set is instilled within the team
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required
Bachelor of Science degree in a related discipline
10-15 years of experience of global regulatory affairs from the pharmaceutical and/or healthcare industry
Significant experience of Leadership of global regulatory strategy and global regulatory teams
Experience of regulatory project management and regulatory agency interactions
Experience of management of regulatory projects in global regulatory organizations
Experience of working globally and across different cultures
Third party management and vendor selection experience (desirable)
Master’s Degree in a related discipline
Ability to lead and inspire
Persuasive, influential, decisive and tenacious
Ability to communicate effectively, both written and verbally, in English
Engenders team work
Ability to juggle and prioritize multiple competing priorities and complete tasks on-time
Ability to assign clear priorities
Locations: United States, United Kingdom; Massachusetts; Marlborough, Amersham
We are in the process of transitioning to an improved job application system and in the interim we are operating with two systems. Have your Job ID ready (from the email you received when you applied) to log in and check your application status.
Click the appropriate button. If you don't know your job ID, you can still check your status: use both buttons.