Regulatory Affairs Publisher ManagerSRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: Regulatory Affairs Publisher Manager Location: (virtual/remote for the right candidate), client is in Richmond, VA areaIndustry: PharmaceuticalHours: Mon-Fri 8AM – 5PM on a part-time basis (roughly 20 hours)Employment Type: Long-term contract and hours could increaseHour Rate: $80.00-$85.00/hr.
Environment: Join a growing pharmaceutical manufacturing company dedicated to providing high-quality, low-cost pharmaceuticals through state-of-the-art, U.S. based advanced manufacturing processes. The company will manufacture precursor chemical ingredients, active pharmaceutical ingredients (API), and finished pharmaceutical products, domestically for essential medicines critical to the ones healthcare.Overview: Works within the Regulatory Affairs Department and serves as a Subject Matter Expert for electronic submissions. Prepares, compiles, and publishes documents for formal electronic submission to regulatory agencies. Performs a review of documentation for submission, identifying gaps as it applies to technical regulatory requirements. Assists in providing guidance and technical support to project teams.Key Responsibilities:
Regulatory Submission: Serve as subject matter expert for publishing of regulatory submissions (in eCTD format), reports, and complex documentsDocument Preparation: Provides assistance as needed with document formatting and compliance with required FDA specifications Process Improvement: Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, mentorship, and specifications
With limited or no supervision, ensure submission of high-quality eCTD compliant dossiers that are in conformance with applicable regulatory guidelines for Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Drug Master File (DMF) submissions Responsible for all stages of submission management including, but not limited to: document preparation, scanning, rendering, bookmarking, hyperlinking, troubleshooting document issues and performance of quality checks of documentation and final validation Directly interfaces with project teams to manage the preparation of their documents; provides expert publishing assistance for all documents critical to regulatory submissions. Ensures documents are compliant with Corporate policies and Guidelines, as well as Regulatory GuidancesReviews compiled submissions prior to being sent to Agency for technical compliance to current regulationsCreate structure product labeling (SPL) files for submissions and drug and establishment listings.Collaborate with vendors who support Regulatory operations related tasks.Prepares new Standard Operating Procedures (SOPs), manages document templates, trains personnel on use of authoring tools and identification of regulatory submission process improvements Maintains Regulatory Affairs electronic archive including agency contact reports and correspondence Stays current with industry expectations and standards. Evaluates processes and works towards applicable improvements to gain efficiency and Right First-Time objectives. Provides mentoring and is an eCTD technical resource for Regulatory, Labelling and R personnelIdentify regulatory system improvement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions
Understanding of Regulatory submission processes from document authoring and management, submission publishing and validation, to regulatory information management and archiveExperience in implementing EDMS applications and RIMS and VIVATechnical experience in handling eCTD publishing tools and ESG requiredPharmaceutical experience (open to dosage form) and working with both ANDAs and NDAs One may assist Quality Assurance with SOP writing, reviewing as wellMust be proficient in MS Teams, MS Office 360 (MS Word, MS Excel, MS Powerpoint), Adobe Acrobat Pro, ISI ToolboxDemonstrated organizational skills, strong verbal and written communication skills, attention to detailAbility to work in a cross-functional team environment with changing timelines and priorities required.
EOE/ADASearch words; RA, regulatory affairs, eCTD, submission, ANDA, NDA, brand, generic
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