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Regulatory Affairs Specialist

2 months ago

Chicago, Illinois, United States Katalyst HealthCares & Life Sciences Full time

Position Overview:
Katalyst HealthCares & Life Sciences Inc. is seeking motivated entry-level professionals for various roles in contract research related to clinical trials involving pharmaceuticals, biologics, and medical devices.

As an E-Verified organization, we welcome candidates on OPT and CPT, and we offer H1B (both CAP and CAP exempt) and Green Card sponsorship for qualified individuals.

We currently have several immediate openings in Regulatory Affairs Operations, CMC, Publishing, and Submission for both Clinical and Non-Clinical sectors. Our collaborations span University hospitals, pharmaceutical firms, and recruitment partners.

Key Responsibilities:


This role will support the preparation and submission of ANDAs, Amendments, Supplements, and Annual Reports to relevant regulatory bodies.

Additionally, the position will assist in the regulatory function through document management, compilation of electronic submissions, and other necessary group management tasks.

Collaboration with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development, Information Technology, and other departments will be essential.

Responsibilities may include submitting changes related to labeling, quality control, manufacturing, or distribution practices. Staying informed on regulatory compliance matters and aiding in the development of new procedures for the Regulatory Department is also expected.

Prepare, compile, review, evaluate, publish, and archive new ANDA submissions and lifecycle management regulatory documents in line with local regulatory standards and guidelines.

Facilitate both paper-based and electronic submissions, including eCTD and non-eCTD formats, for multiple projects to regulatory agencies, ensuring the timely and quality delivery of submissions.

Conduct thorough reviews of submission documentation and provide constructive feedback to relevant departments for necessary amendments.

Coordinate and prepare responses to FDA Deficiency Letters and other requests from regulatory agencies.

Utilize eCTDXpress to complete submission publishing for submissions through ESG.

Qualifications:
A Bachelor’s or Master’s degree in a scientific discipline or equivalent education and experience is required.

A minimum of 1-3 years of relevant experience in the pharmaceutical sector, ideally in drug regulatory affairs, analytical roles, quality assurance, research and development, or production, is preferred.

Familiarity with US Regulatory Operations and Submissions is essential.

All information will be treated confidentially in accordance with EEO guidelines.

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