Biologics, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
B&H Consulting Services, Inc., a VCLS Company, is seeking an experienced CM&C Regulatory Affairs professional to work on site, who will be involved in formulating and executing CM&C and regulatory strategy via submissions across multiple therapeutic areas. B&H Consulting Services, Inc., located in central New Jersey, provides global regulatory affairs support and technical writing expertise to the health sciences industry.
This position offers opportunities for growth and a competitive compensation package, i.e., salary, vacation, bonus, 401K savings and profit sharing plan, health, disability and life insurance.
Key duties include coordination, planning, writing and preparation of CM&C documents for global investigational and marketing applications. Experience with biologic products a plus. The CM&C Regulatory Affairs Specialist will be responsible to communicate with the client throughout the project, establish timelines, agree on content and format of submissions, review/assess technical documents for completeness, interact with health authorities, write CM&C technical documents, provide filing strategy and manage multiple activities to support submissions.
Must have a strong understanding of regulatory and compliance guidelines, knowledge and experience with eCTD, and ability to interpret and apply regulations as they apply to specific project issues. Candidate must be professional, organized, detail-oriented, possess excellent CM&C technical writing and verbal communication skills, meet project timelines, and serve on client project teams. The CM&C Regulatory Affairs Specialist requires 2-4 years of previous experience in CMC regulatory affairs, pharmacy or pharmaceutical industry (analytical chemistry, drug development, formulations, biologics, quality assurance/control or manufacturing) and a minimum of a Bachelor’s degree in a scientific discipline; RAC and/or Master’s degree preferred.
Additional Salary Information: salary, vacation, bonus, 401K savings and profit sharing plan, health, disability and life insurance.
Internal Number: BH-CMC PM
About B&H Consulting Services, Inc.
B&H Consulting Services, Inc., a VCLS Company, located in central New Jersey, provides global regulatory affairs and technical writing expertise to a client list of more than 70 active US and international clients that include Top 10 pharmaceutical and biotechnology corporations. Our team interacts with FDA on a daily basis as US Agent for more than 40 companies. The company is seeking qualified individuals to fill new full-time positions within our expanding organization. These positions offer opportunities for growth and a competitive compensation package, i.e. salary, vacation, bonus, 401K plan, health, disability and life insurance.