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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