Regulatory Project Manager

Regulatory Project Manager

Biologics Consulting, Inc. (BC) seeks to hire a full-time Project Manager (PM) with ‘hands-on’ experience in the Biotech, Pharmaceutical Industry, or FDA Project Management environment (required). The successful candidate will be able to work independently, be a self -starter, with strong oral and written communication skills, and have the ability to multi-task. The Project Manager is responsible for working directly with Clients, BC Consultants and internal staff members.

Candidate may work predominantly from home; however, must be located in reasonable proximity to work in BC’s Alexandria, Virginia office, on occasion as necessary.

Key Accountabilities:

  • Author and/or coordinate proposal development for multi-disciplinary projects
  • Coordinate and prepare responses to RFP’s (request for proposals)
  • Coordinate the activities and output of multi-disciplinary Consultant teams assigned to Projects.
  • Lead or assist with preparation of business development proposals and responses to RFP’s (request for proposals).
  • Coordinate and prepare LOI’s (letter of intents)
  • Provide project management support, including but not limited to:
    • Project budget analyses
    • Timeline development and tracking
    • Document exchange workspace implementation and maintenance
    • Communication facilitation among team members (BCG and client)
    • Document tracking/version control, collection and organization
  • Keep abreast of relevant FDA regulations and apply such knowledge and guidance to Client projects
  • Attend industry relevant meetings to advance current knowledge base and leverage business development opportunities with Clients and potential Clients.
  • Miscellaneous Administrative duties as necessary

Basic Qualifications:

  • BS/MS in Natural Sciences, Project Management, or Nursing
  • Experience in the Biotech, Pharmaceutical Industry, or FDA Project Management environment (Required).
  • 2+ years managing cross-functional projects/teams using project management methodologies and tools for complex product/process development environments
  • Working familiarity with FDA and/or ICH regulations
  • Prior experience in interacting with FDA (CBER, CDER) in project review capacity

Preferred Qualifications:

  • Advanced degree (e.g. MS, Ph.D) in Natural Sciences
  • Project Management Professional (PMP) Certification


Proficient in Microsoft Office Suite, keyboard skills, oral and written communications skills, strong documentation skills, math aptitude, diplomacy, professionalism, organization, time management, ability to multi-task, able to work unsupervised, able to maintain confidentiality

Education and/or Experience:

College Degree required – preferred in field of Biology, Natural Sciences or Regulatory Affairs. Prior experience in regulatory affairs is advantageous.

Biologics Consulting Group, Inc. (BCG) is an international consulting firm whose consultants provide national and international regulatory and product development advice on the development and commercial production of biological, drug, and device products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Many of our consultants are former CBER, CDER and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry. We offer a great work environment, as well as a highly competitive salary and benefit package, including healthcare and 401k plans.

An immediate start is preferred.