Biologics Consulting is always seeking highly talented, subject matter experts with considerable experience in their specific areas of scientific expertise who can provide high-quality scientific, manufacturing, regulatory support and product commercial development expertise to biologics, drug and device manufacturers, government and non-government, and academic institutions.
Our Senior Regulatory Consultants provide regulatory and compliance guidance to domestic and international clients. Consultants must possess the level of training and experience required to function independently to provide consulting needs to clients related to specific tasks. Our consultants are involved in the preparation, review and management of CBER, CDER and CDRH regulatory submissions. They also provide guidance for timely remediation and recommendations regarding acceptability of regulatory submissions, and develop compliance strategy, including involvement with product escalation discussions associated with critical deviations, complaints, etc.
The preferred candidate should have a Ph.D. (in a biological or health-related science) or an MD, and at least 8 or more years of experience within the biotechnology industry, clinical laboratories, and/or a national regulatory authority such as the US Food and Drug Administration. This is a full-time, salary plus performance based bonus position.
If you have the background that qualifies you for a career at Biologics Consulting, please send your curriculum vitae to the link below.
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-five 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.
Biologics Consulting is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.