Regulatory Affairs Specialist

Summary: Seeking a Regulatory Affairs Specialist to support international drug product applications and manage regulatory activities for market expansion.

• Requirements:

  • Bachelor's degree in scientific discipline
  • 3+ years of regulatory experience or related field
  • Background in manufacturing, research and development, or quality assurance

• Preferred Skills:

  • Use of software systems for managing change controls
  • Authoring and organizing CTD regulatory filings

• Responsibilities:

  • Plan, author, compile drug product dossiers for international markets
  • Manage variations for marketed products outside the US
  • Respond to health authority information requests to achieve approval
  • Review CMC regulatory impact and provide post-approval change strategies

Pay Details: $30.00 to $34.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. 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.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance