Regulatory Affairs Specialist jobs in Chicago, IL

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 office.

Job Types: Full-time, Contract

Pay: $37.50 - $40.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person