Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Job Summary:
We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with all relevant regulations and guidelines in the pharmaceutical industry. Your expertise in clinical trials, research, and FDA regulations will be essential in supporting our company's mission to deliver safe and effective products to our customers.
Duties:
- Develop and implement regulatory strategies for new product development and product lifecycle management
- Prepare and submit regulatory submissions, including INDs, NDAs, ANDAs, and annual reports
- Review and interpret regulations and guidelines to ensure compliance with FDA requirements
- Collaborate with cross-functional teams to provide regulatory guidance throughout the product development process
- Conduct regulatory assessments of proposed changes to products or manufacturing processes
- Coordinate and support regulatory inspections and audits
- Maintain up-to-date knowledge of current regulations, guidelines, and industry best practices
- Assist in the development of standard operating procedures (SOPs) related to regulatory affairs
- Support quality assurance activities related to regulatory compliance
Skills:
- Strong knowledge of FDA regulations and guidelines for pharmaceutical products
- Experience with Chemistry Manufacturing Controls (CMC) requirements
- Familiarity with clinical trial regulations and processes
- Excellent project management skills, with the ability to prioritize tasks and meet deadlines
- Detail-oriented with strong analytical skills
- Effective communication skills, both written and verbal
- Ability to work collaboratively in cross-functional teams
We offer competitive compensation packages commensurate with experience. This is a full-time position based at our
Job Types: Full-time, Contract
Pay: $37.50 - $40.00 per hour
Benefits:
Schedule:
Work Location: In person