What are the responsibilities and job description for the Regulatory Affairs Associate position at Cynet Systems?
Job Description:
Pay Range: $30.26hr - $34.26hr
Pay Range: $30.26hr - $34.26hr
- 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.
- 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.
- Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint.
Salary : $30 - $34
