The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
familiarity with documents normally included in FDA submissions
familiarity with all FDA electronic submissions guidance documents
ability to communicate clearly with clients regarding ongoing projects
attention to detail
ability to work on multiple projects simultaneously while maintaining deadlines
ability to work on projects involving large numbers of documents
requires minimal instructions on routine work and new assignments
comfortable working in a team environment
Biologics Consulting Group, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, protected veteran status or status as an individual with a disability.
Internal Number: 03-2021
About Biologics Consulting Group, Inc.
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-six years since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients internationally to address nonclinical, clinical, product development and manufacturing, and regulatory compliance challenges.
The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience. Biologics Consulting offers a great work environment, as well as a highly competitive salary and benefit package, including healthcare, 401k, and ESOP plans.