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Regulatory Affairs Specialist
COMMERCIAL METALS
Chicago, Illinois

3 months ago

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

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