Current Job and Project Opportunities

Posting: FDAAA Posting no. 2021-3

Job/Opportunity: Senior Regulatory Project Manager

Organization: B & H Consulting Services, Inc.

B&H Consulting Services, Inc. is looking to hire a Senior Regulatory Project Manager.  Check out B&H at www.bhconsultingservices.com

Looking to use your FDA experience in a consulting environment? If so, there is a senior-level opportunity at B&H Consulting Services, Inc. that may pique your interest.

Based in Somerville, NJ, B&H’s professional team works with our clients to develop regulatory strategy and seamlessly lead projects to ensure that the goals and milestones are achieved. Founded in 1988, B&H’s team has strong scientific and business backgrounds and hands-on development experience. We focus on our clients’ specific needs to deliver support from development through lifecycle management. B&H specializes in the planning, organizing, and conducting of successful Sponsor/FDA meetings, as well as provides proven CMC technical writing expertise.

Senior Regulatory Project Manager:

  • Design and execute regulatory strategy to ensure expedited product development and commercialization for products across therapeutic areas.
  • Coordinate with clients to provide regulatory strategy, guidance, and submission support.
  • Author, review and assemble regulatory documents to support INDs, NDAs, BLAs, ODDs.
  • Support all activities related to FDA meetings, including preparing meeting requests, briefing packages, and leading FDA meetings on the Sponsor’s behalf.
  • As US or Regulatory Agent, lead multiple projects at different stages of development.
  • Ensure compliance with regulations/guidelines.
  • Provide leadership to the regulatory team members through training/mentoring.

Reach out with any questions to:

Barry Rudner, SHRM-CP, PHR

Director, Human Resources

brudner@bhconsultingservices.com

Direct Dial: 908-219-8866

Office: 908-704-1691 x206