Job summary
Job post source
This job is directly from Katalyst CRO
Job overview
The Regulatory Affairs Specialist at Katalyst CRO manages regulatory submissions and compliance to ensure pharmaceutical products meet global regulatory standards, impacting drug approval and market access.
Responsibilities and impact
The role involves assessing CMC changes, preparing and organizing regulatory submission packages, authoring and reviewing CMC regulatory documents, ensuring compliance with FDA, EMA, and global regulations, performing technical reviews, and supporting ad-hoc CMC requests using multiple regulatory systems.
Experience and skills
Candidates need a bachelor's degree in health or life sciences with 5+ years pharmaceutical experience, strong technical document interpretation skills, experience authoring CMC regulatory filings, proficiency in MS Office, familiarity with CTD formatting, and preferred knowledge of US/EU regulations and regulatory tools like TrackWise and Veeva Vault.
Company overview
Katalyst CRO is a contract research organization specializing in providing comprehensive clinical trial management and support services to pharmaceutical, biotechnology, and medical device companies. They generate revenue by offering tailored solutions in clinical operations, regulatory affairs, data management, and biostatistics to accelerate drug and device development processes. Founded with a focus on innovation and efficiency, Katalyst CRO emphasizes collaboration and cutting-edge technology to deliver high-quality results. Their expertise spans multiple therapeutic areas, making them a trusted partner in advancing healthcare solutions globally.
How to land this job
Tailor your resume to emphasize your experience with CMC regulatory documents, including authoring and reviewing Core Dossiers, INDs, CTAs, and MAAs, as these are central to the Regulatory Affairs Specialist role at Katalyst CRO.
Highlight your familiarity with FDA, EMA, and global regulatory requirements, showcasing your ability to interpret and apply these regulations to ensure compliance in submissions and documentation.
Demonstrate your proficiency with regulatory systems and tools such as TrackWise and Veeva Vault, along with strong MS Office skills, to align with the operational and technical demands of the job.
Apply through multiple channels including Katalyst CRO’s corporate careers page and LinkedIn to maximize your visibility and chances of being noticed by recruiters.
Connect with current Regulatory Affairs professionals at Katalyst CRO on LinkedIn, using ice breakers like asking about recent regulatory challenges they have faced or their experience with the company’s submission processes to start meaningful conversations.
Optimize your resume for ATS by incorporating key phrases from the job description such as 'CMC regulatory documents,' 'FDA and EMA compliance,' 'TrackWise,' 'Veeva Vault,' and 'Common Technical Document (CTD) formatting' to ensure it passes automated screenings effectively.
Leverage Jennie Johnson's Power Apply feature to automate applying across multiple job boards, tailor your resume for ATS, and identify LinkedIn contacts within Katalyst CRO, allowing you to focus your time on networking and interview preparation.
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