Regulatory Affairs Specialist
2 weeks ago
Position Overview:
Katalyst HealthCares & Life Sciences Inc. is seeking entry-level professionals for various roles in contract research focused on 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 immediate openings in Regulatory Affairs Operations, CMC, Publishing, and Submission for both Clinical and Non-Clinical sectors. Our collaborations include university hospitals, pharmaceutical firms, and recruitment partners.
Key Responsibilities:
This role involves assisting in the preparation and submission of ANDAs, Amendments, Supplements, and Annual Reports to relevant regulatory bodies.
Support for the regulatory function will include document management, electronic submission compilation, 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 also include submitting requests for changes 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 will be required.
Prepare, assemble, review, evaluate, publish, and archive new ANDA submissions and manage life cycle regulatory submissions in accordance with local regulatory standards and guidelines.
Prepare both paper-based and electronic submissions, including eCTD and non-eCTD formats, for multiple projects to regulatory agencies, ensuring timely and quality submissions.
Critically assess submission documentation and provide constructive feedback to relevant departments for necessary adjustments.
Coordinate and prepare responses to FDA Deficiency Letters and other agency inquiries.
Utilize eCTDXpress to complete submission publishing for regulatory submissions through ESG.
Qualifications:
A BS or MS 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, QA, R&D, or production, is preferred.
Familiarity with US Regulatory Operations and Submissions is essential.
All personal information will be kept confidential in accordance with EEO guidelines.
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