Regulatory Affairs Project Manager
DataRevive USA LLC is a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filing of US IND, BLA, and NDA during drug development. We specialize in both small molecule and biologic product regulatory affairs with specific expertise in CMC (chemistry, manufacturing, controls), nonclinical, clinical pharmacology and clinical areas. For more information, go to www.data-revive.com.
The Regulatory Affairs Project Manager is responsible for various day-to-day functions related to client interactions, document publishing, submission compilation, regulatory information management, and submission management among other tasks as required. Under the direction of the Senior Director, Regulatory Affairs, this individual will support various regulatory application types including INDs, NDAs, MAA and related amendments/supplements in eCTD format. 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:
- Manage client interactions
- Ability to manage multiple regulatory projects with concurrent or competing deadlines
- Track and maintain timelines and Gantt charts for client deliverables
- Manage regulatory submission publishing deliverables on a day to day basis to ensure successful execution of operational activities
- Hands 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 ready
- Responsible for assembly, publishing and compilation of IND, NDA, MAA, CTA submissions using eCTD publishing tools
- Maintain proficiency and expertise with the eCTD publishing tools, processes and regulations associated with global regulatory submissions
- Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications
- Perform U.S. and international regulatory research tasks as related to regulations and Regulatory Technology and Operations
- 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
- Participate in creation, review and implementation of department Standard Operating Procedures (SOPs), Work Instructions (WIs), and checklists
- Interface with Project Managers, Regulatory Leads, Discipline Leads, and/or content authors to provide technical guidance and support in finalizing submission content
- 3-5 years of direct Regulatory Operations experience with publishing, compiling, QC, Validating electronic submissions (IND, MAA, NDA, CTAs)
- Understanding of eCTD ICH and regional guidance’s
- Ability to apply knowledge and understanding of US FDA laws, regulations, guidance documents, SOPPS, MAPPs to advise clients through the drug development process
- Ability to apply knowledge and understanding of ICH guidelines to advise clients through the drug development process
- Mid- level experience with eCTD templates and Microsoft Office tools
- Technical knowledge of electronic publishing tools/document management systems and software
- Organized, team oriented, detail oriented, and able to handle multiple projects concurrently
- Excellent verbal and written communication skills
- Ability to work in a fast-paced environment that is primarily timeline-driven
- Microsoft Office Suite (key focus on Word, Excel and PowerPoint and Visio), Adobe Acrobat, ISI/TRS Toolbox, eCTD publishing tools, archiving/ filing/RIM activities, Veeva Vault experience desired
- Proficient in Adobe or other document publishing tools
- Proficient in eCTD tools like Global Submit, eCTD Express, Veeva publishing
- Chinese fluency is a plus
- 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. We guarantee that you will have tremendous learning opportunities and will be 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.
About DataRevive LLC:
We are a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filing of US IND/ BLA/NDA during drug development. We specialize in both small molecule and biologic product regulatory affairs. We have expertise in the CMC, nonclinical, clinical pharmacology, different clinical areas and regulatory management.
Job posted: 2020-08-28