Job Description
**Job Title:** Regulatory Affairs Specialist
**Industry:** Pharmaceutical
**Location:** Chicago, IL
**About Us:**
Leoforce is the innovative company behind Ira, the AI-powered recruiting technology that revolutionizes talent discovery and engagement. At Leoforce, we are passionate about empowering recruiters and job seekers with responsible AI that delivers unbiased, data-driven results. We foster a workplace built on respect, integrity, and the freedom to innovate.
**Why Join Us?**
- Career Growth: Opportunities for professional and personal advancement in a rapidly evolving industry.
- Cutting-Edge Technology: Be part of a team working on revolutionary AI solutions that redefine talent acquisition.
- Collaborative Environment: A culture that values diversity, creativity, and high performance.
- Employee Empowerment: Freedom to innovate and make a difference while being supported by a team that values respect and integrity.
**Position Summary:**
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team in Chicago, IL. The ideal candidate will have experience in the pharmaceutical industry and a strong understanding of regulatory requirements and processes. You will play a key role in ensuring compliance with all applicable regulations and supporting product registrations and submissions.
**Key Responsibilities:**
- Prepare, review, and submit regulatory documents to FDA and other regulatory agencies.
- Maintain up-to-date knowledge of regulatory requirements and industry standards.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to ensure regulatory compliance throughout product lifecycle.
- Monitor and interpret regulatory changes, providing guidance to internal teams.
- Support product registrations, renewals, and amendments as needed.
- Maintain regulatory files and documentation in accordance with company policies and procedures.
- Communicate with regulatory authorities as required.
**Qualifications:**
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field.
- 2+ years of regulatory affairs experience in the pharmaceutical industry.
- Strong knowledge of FDA regulations and submission processes.
- Excellent written and verbal communication skills.
- Detail-oriented with strong organizational and project management abilities.
- Ability to work independently and collaboratively in a fast-paced environment.
**Preferred Qualifications:**
- Regulatory Affairs Certification (RAC) is a plus.
- Experience with international regulatory submissions is desirable.
**Benefits:**
- Competitive salary and benefits package
- Opportunities for career advancement
- Supportive and innovative work environment
- Access to cutting-edge technology and resources