Job summary
Job post source
This job is directly from United Pharma Technologies Inc
Job overview
The Regulatory Affairs Specialist role at United Pharma Technologies Inc involves managing regulatory compliance and quality documentation to ensure products meet FDA and international standards.
Responsibilities and impact
The specialist will gather and analyze product information, design and validate cGxP systems, prepare and submit quality compliance documentation, and conduct risk management and root cause analysis.
Experience and skills
A Master's degree in relevant scientific or engineering fields and at least 6 months of related experience are required, with skills in EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC, and eCTD.
Job location and travel
The position is based in Iselin, NJ, with potential travel to various unanticipated locations across the U.S.
Application process
Applicants must send their resume to the HR Department at United Pharma Technologies Inc, located at 120 Wood Avenue South, Suite 406, Iselin, NJ 08830.
Company overview
United Pharma Technologies Inc. is a pharmaceutical and biotechnology company specializing in the development, manufacturing, and distribution of innovative healthcare solutions. The company generates revenue through the production of proprietary drugs, contract manufacturing services, and partnerships with healthcare providers and research institutions. Founded with a mission to address unmet medical needs, United Pharma Technologies has a history of significant contributions to therapeutic advancements, particularly in oncology and rare diseases. Candidates should note its emphasis on cutting-edge research, regulatory compliance, and global market expansion strategies.
How to land this job
Tailor your resume to highlight your knowledge and experience with regulatory compliance standards such as EU MDR, ISO 13485, cGMP, and MDSAP, emphasizing any hands-on involvement with IQ/OQ/PQ qualification and validation processes.
Showcase your ability to manage documentation for quality compliance, including submission preparation, review, and authorization, as well as your skills in risk management, gap analysis, and traceability matrix development.
Apply through multiple channels including United Pharma Technologies’ corporate website, LinkedIn, and reputable job boards to maximize your application’s visibility.
Connect on LinkedIn with professionals working in the Regulatory Affairs division at United Pharma Technologies, initiating conversations by referencing recent regulatory updates or asking about the company’s approach to FDA compliance and cGxP systems.
Optimize your resume for ATS by including key terms from the job description such as '21CFR Part11,' 'FDA listing numbers,' 'GMDN codes,' 'qualification & validation,' 'risk management plans,' and 'eCTD' to ensure it passes automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate resume tailoring, multi-channel application submission, and LinkedIn networking, freeing up your time to focus on interview preparation and skill development.
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