Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Job Description
We are seeking a Manager of Regulatory Affairs to join our ITI team. The ideal candidate will have experience in development of regulatory documents for filing with the FDA (e.g., Meeting documents, INDs submissions, Annual Reports, etc.). The candidate will provide regulatory support for ITI’s development projects and regulatory documents for filing with the FDA. The candidate will also collaborate with ITI teams to deliver commitments to the organization and to patients.
Responsibilities
Organizational Relationships
Qualifications
Technical/Behavioral Skills/Competencies
Physical Requirements
Work Environment
Position Type and Expected Hours of Work
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Please visit our careers site at http://www.immunomix.com/careers/. Send your cover letter and credentials as described on the Careers page along with the Job Code: 2024 RA003 in the subject line.
Equal Opportunity Employer
Job Type: Full-time
Pay: $140,000.00 - $160,000.00 per year
Benefits:
Schedule:
Ability to Relocate:
Work Location: In person