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Sr. Project Manager, Regulatory Affairs

Company: DataRevive
Location: Rockville
Posted on: March 13, 2023

Job Description:

Company Summary:DataRevive USA LLC is a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filing of a US Pre-IND, IND, BLA, and NDA during their drug development. We specialize in both small molecule and biologic products, with specific expertise in regulatory affairs, CMC (chemistry, manufacturing, controls), nonclinical, clinical pharmacology and clinical areas. For more information, go to Position Summary:The Senior Project Manager, Regulatory Affairs is responsible for various day-to-day functions related to managing various regulatory projects, including managing client interactions and project deadlines, providing strategic regulatory advice; as well as developing an overall project plan that will allow clients to make key business decisions regarding the development of potential pharmaceutical products (i.e. small molecule drugs, biologics, etc.) intended for research and development to treat a specific disease. The Senior Regulatory Affairs Project Manager will work closely with discipline specific teams and is responsible for the overall management of the project goals, maintaining confidential client regulatory information, managing project timelines, managing all client interactions, developing the documentation necessary to support the regulatory submission; and, managing the final submission of the Pre-IND, IND, BLA, or NDA (including document formatting, publishing, and submission compilation) to the appropriate regulatory health agency (e.g. US FDA). -Under the direction of the Director or Senior Director, Regulatory Affairs, this individual will support - -various regulatory application types including INDs, NDAs, BLAs, and related - -amendments/supplements in eCTD format to the US FDA. The successful candidate will ensure - -submissions and related documentation are prepared in compliance with various health agency - -regulations and guidelines. This role will coordinate and liaise with external submission vendors to - -manage submission compilation, validation and dispatch.Essential Duties & Responsibilities:

Ability to manage multiple regulatory projects with concurrent or competing deadlines while working closely with discipline specific team members; including other Regulatory Project Managers, Regulatory Leads, Discipline Leads, Discipline Specific Consultants, Medical Writers, and/or content authors to provide regulatory and technical guidance to support submission content;Provide regulatory affairs/business development advice to clients to allow them to make key decisions regarding product asset development;Manage all client interactions (including timelines, budgets, forecasting submission target dates) utilizing tracking tools/software to develop and maintain and track timelines and -project budgets (including Gantt charts, Excel spreadsheets, and internal software for client deliverables);Maintain proficiency with US FDA laws, regulations, guidance documents, Standard Operating Procedures and Policy (SOPPs), Manual of Policy and Procedures (MAPPs), etc. as they pertain to drug development;Maintain proficiency with ICH drug development guidelines;Maintain proficiency and expertise with the eCTD publishing tools, processes and regulations associated with global regulatory submissions to allow for successful submissions to the FDA;Ensure appropriate project close out and archiving of US FDA regulatory submission filings, correspondence and related information for various types regulatory applications (IND, NDA, BLA);Perform U.S. and international regulatory research and due diligence tasks to assess a prospective company or a specific asset for potential acquisitions;Participate in creation, review and implementation of department Standard Operating Procedures (SOPs), Work Instructions (WIs), and checklistsMinimum Qualifications:
Bachelors Degree or higher in Biology, Biological Technology or similar -and/or 5-10 years of previous experience working for a regulatory consulting firm, or at a pharmaceutical or biotechnology company, or at the FDA (CDER,CBER,CDRH) specializing in US regulatory affairs for small molecule or biologic products and applications; managing regulatory projects/submissions to CDER or CBER at the US FDA or an equivalent combination of years of experience/educationHands on experience with document level publishing of submission components (e.g.: clinical protocols/amendments, nonclinical reports, CSRs, related regulatory documentation, etc.) and prepare them to be submission readyComprehensive understanding of eCTD ICH and regional guidances including experience with eCTD templates (Module 1 through Module 5) and Microsoft Office tools, and Adobe or other document publishing tools (Global Submit and DocuBridge)Comprehensive understanding of US FDA laws, regulations, guidance documents, SOPPS, MAPPs to advise clients through the drug development processAbility to apply knowledge and understanding of FDA regulations and ICH guidelines to advise clients through the drug development processHighly organized, team oriented, detail oriented, and able to handle multiple projects with concurrent deadlines Excellent verbal and written communication skills Demonstrated ability to work in a fast-paced environment that is primarily timeline-drivenDemonstrated skills using Microsoft Office Suite products (key focus on Word, Excel and PowerPoint and Visio); and Adobe AcrobatMulti-lingual language skills, including Chinese fluency is a plusPhysical Requirements
Prolonged periods of sitting at a desk and working on a computer.What we offer you:You'll be a member of a phenomenal group of business professionals that have an innovative and team approach to success, based out of Rockville, MD. - DataRevive offers -tremendous learning opportunities and employees are -actively encouraged to creatively contribute. Our benefits are comprehensive and include medical, dental, vision, 401(k) matching, and generous flexible vacation and sick time allowances. DataRevive USA LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Validant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Powered by JazzHR

Keywords: DataRevive, Rockville , Sr. Project Manager, Regulatory Affairs, Executive , Rockville, Maryland

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