Job Description

DUTIES:

• Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.) within a defined time schedule.
• Help determine regulatory strategies for manufacturing changes and regulatory activities.
• Aid in preparing Lifecycle Management like Annual Reports (Product, DMF).
• Coordinate and track workflows for regulatory submissions.
• Ensure regulatory submissions meet global standards.
• Participate in meetings and interact with project team members and sub-teams.
• Assist with and eventually lead licensing activities and required updates (Establishment Registration, California State License, State licensing).
• Support reporting requirements under the CARES Act.
• Provide support to Regulatory management as needed.

• PC literacy is required.
• Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project), Document Management Systems and Internet resources, is expected.
• General knowledge and application of global regulations and cGMP requirements are necessary.
• Must be able to work independently and with appropriate supervision.
• Excellent organizational, interpersonal, and communication skills (oral and written) are required.

• A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required.

Job Tags

Similar Jobs