General Electric Regulatory Affairs Manager, Labeling in Marlborough, Massachusetts
Job Description Summary
This person will join a highly competent team of Regulatory Professionals supporting diagnostic pharmaceutical products.
In this role, you will provide regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product labeling submissions/registrations and post-market compliance, working closely with US FDA and Health Canada.
Roles and Responsibilities
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product labeling submissions/registrations and post market compliance, working closely with US FDA and Health Canada.
Utilizes in-depth knowledge of the labeling RA discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
Acts as a resource for colleagues with less experience. Lead labeling projects. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
Functions with autonomy subject to functional practices and precedents. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
Uses judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and external sources outside of own team to arrive at decisions.
Bachelor's degree (science related)
2+ years experience in Pharmaceutical Regulatory Affairs
Must be able to work with other GE teams cross functionally
6+ years experience in Pharmaceutical labeling
New drug labeling development experience
Post marketing labeling experience
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . 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.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Relocation Assistance Provided: No