Regulatory Affairs Manager, Labeling

11 Jul, 2021

Jobs

Regulatory Affairs Manager, Labeling

GE Healthcare
Remote

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.

***This role can be based remotely.

Job Description

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.

Required Qualifications

  • Bachelor’s degree (science related)
  • 2+ years experience in Pharmaceutical Regulatory Affairs
  • Detail oriented
  • Must be able to work with other GE teams cross functionally

Preffered Qualifications

  • 6+ years experience in Pharmaceutical labeling
  • New drug labeling development experience
  • Post marketing labeling experience

#LI-BR1

Additional Information

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.

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

About Us
GE (NYSE:GE) rises to the challenge of building a world that works. For more than 125 years, GE has invented the future of industry, and today the company’s dedicated team, leading technology, and global reach and capabilities help the world work more efficiently, reliably, and safely. GE’s people are diverse and dedicated, operating with the highest level of integrity and focus to fulfill GE’s mission and deliver for its customers. www.ge.com

Job posted: 2021-07-11