Regulatory Project Manager
Biologics Consulting, Inc. (BC) seeks to hire a full-time Regulatory Project Manager (RPM) with ‘hands-on’ experience in the Biotech, Pharmaceutical Industry, or FDA Project Management environment. The successful candidate will be able to work independently, able to multi-task, be a self-starter, have strong oral and written communication skills. The RPM is responsible for working directly with Clients, BC Subject Matter Experts (SMEs), BC affiliates and internal staff members.
Candidate may work from home during the ongoing public health situation; however, may need to be within reasonable distance of BC’s Alexandria, Virginia office, in the future.
- Well versed in current FDA regulations, policies, and guidelines applicable to CDER and CBER.
- Experience managing preparation, organization and submission of Meeting Requests and Briefing Packages, INDs, BLAs, NDAs & all regulatory documents/submissions critical to product life cycle.
- Interacting with FDA on behalf of clients for regulatory matters.
- Experience as the designated Regulatory Contact or U.S. Agent for a client.
- Coordinate activities and output of multi-disciplinary teams assigned to Projects.
- Provide project management support, including but not limited to:
- Guidance on FDA requirements
- Project budget analyses
- Timeline development and tracking
- Document exchange workspace implementation and maintenance
- Communication facilitation among team members (BC and client)
- Document tracking/version control, collection, and organization
- Author and/or coordinate proposal development for multi-disciplinary
- Lead or assist with business development proposals & responses to RFP’s (request for proposals).
- Keep abreast of relevant FDA regulations and apply such knowledge/guidance to 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.
- BS/MS in Natural Sciences, Pharmacy, Nursing, or Regulatory Affairs
- Experience in the Biotech, Pharmaceutical Industry, or FDA Project Management environment.
- 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 related to drug and biologics products.
- Prior experience interacting with FDA (CBER, CDER) in project review capacity.
- Familiarity with IND/BLA/NDA/ANDA and/or ODD submissions.
- Advanced degree (e.g., MS, PhD)
- Project Management Professional (PMP) Certification
Proficient in Microsoft Office Suite, oral and written communications skills, strong documentation skills, professionalism, organizational and time management skills, ability to multi-task, ability to work independently, ability to maintain confidentiality, familiarity with Smartsheet a plus.
Education and/or Experience:
College Degree required.
An immediate start is preferred.