Automation Regulatory Specialist

7 days ago


Bloomfield Hills, Michigan, United States Entegee Full time
Job Overview

Entegee, a leading provider of custom automation projects, is seeking an experienced Regulatory Affairs Specialist to join their team.

Salary Range: $36.00 - $48.00 per hour

Key Responsibilities

The successful candidate will be responsible for ensuring that company products comply with all regulatory requirements and standards for safety and efficacy.

Required Skills and Qualifications:

  • Bachelor's degree in a scientific or healthcare-related field.
  • 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • In-depth knowledge of FDA regulations, ICH guidelines, and global regulatory requirements.
  • Experience with regulatory submissions, including INDs, NDAs, BLAs, and post-approval supplements.
  • Strong project management skills with the ability to manage multiple projects simultaneously.
  • Ability to collaborate with cross-functional teams, including R&D, clinical, and quality departments.

Preferred Skills:

  • Advanced degree (MS or PhD) in life sciences or a related field.
  • Experience with electronic submission platforms (eCTD).
  • Previous experience with biologics or advanced therapies.
  • Knowledge of regulatory pathways for new drug applications in the EU, Japan, and other international markets.
  • Certification in Regulatory Affairs (RAC).

Benefits:

Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Company Description:

Entegee specializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. Our goal is to expand your resume and build you to be a top performing controls engineer.



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