Regulatory Affairs Specialist
2 weeks ago
Position Overview:
Katalyst HealthCares & Life Sciences Inc. is seeking 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 extend to 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.
Additionally, the position supports regulatory functions through 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 is essential.
Responsibilities may 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 is also required.
Tasks include preparing, assembling, reviewing, evaluating, publishing, and archiving new ANDA and lifecycle management regulatory submissions in line with local regulatory standards and guidelines.
Both paper-based and electronic submissions, including eCTD and non-eCTD formats, must be prepared for multiple projects to regulatory agencies, ensuring timely and quality submissions.
Critical review of submission documentation and providing feedback to relevant departments for necessary adjustments is expected.
Coordination and preparation of responses to FDA Deficiency Letters and other agency inquiries are also part of the role.
Utilizing eCTDXpress for submission publishing through ESG is required.
Qualifications:
A BS or MS in a scientific discipline or equivalent education and experience is necessary.
A minimum of 1-3 years of prior experience in the pharmaceutical sector, particularly in drug regulatory affairs, analytical roles, QA, R&D, or production, is preferred.
A solid understanding of US Regulatory Operations and Submissions is essential.
All information will be kept confidential in accordance with EEO guidelines.
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