Regulatory Affairs Specialist/Manager


Position Summary

The Regulatory Affairs Specialist/Manager will work with the Operations department to compile documentation related to the products that are produced at Gemini to ensure compliance across multiple geographical locations.  This candidate will assist in the proper labeling of the products produced at Gemini manufacturing facilities.  The ideal candidate should have knowledge in regulations related to cGMP and device GMP as well as the regulations in other jurisdictions like Europe, Asia and Australia.  This candidate will participate in audits as needed and support filings that Gemini will perform.  The Regulatory Affairs Specialist/Manager will work closely with the operations team, directly report to the CEO and indirectly report to the COO.

Reporting Relationships

Direct Supervisor: CEO

Indirect Supervisor: COO

Key Responsibilities

  • Confirm compliance for marketed products based on labeling claims with respect to all regions that the products will be sold
  • Assist in audits as needed
  • Prepare and submit filings for the different regulatory organizations
  • Work with Operations to assemble quality and compliance dossiers for the various products
  • Work with Operations to perform gap assessments for customers related to their products
  • Prepare filings for different jurisdictions 

Required Skills/Abilities

  • Understanding of 21CFR600, 820 and ISO13485 regulations
  • Experience in regulatory filings with FDA and other major regulatory agencies
  • Good written and verbal communication skills
  • Have had direct communication with regulatory agencies

Personal Attributes

  • Displays understanding of and promotes company and customer objectives
  • Readily adapts to changing job duties
  • Works well in a team environment
  • Detail oriented
  • Responds quickly to assignments
  • Positive attitude

Required Skills and Experience

  • Degree in a science related field
  • > 7-years of relevant regulatory experience in a biopharmaceutical manufacturing or equivalent experience in a current Good Manufacturing Practices (cGMP) or technical manufacturing environment
  • Knowledge of general, technical and manufacturing operations
  • A proven ability to work as part of a team to deliver results
  • Organization Skills – Ability to manage multiple priorities and know when to escalate issues for resolution
  • Effective Communicator
  • Good level of understanding with Microsoft Office Products (Word, Excel)

Company Values

  • Adaptable
  • Results driven
  • Decisive
  • Reliable
  • Innovative
  • Confident
  • Ethical

Job Type: Full-time

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