B&H Consulting Services, Inc., a VCLS Company, is seeking an experienced Regulatory professional to work on site, who will be involved in formulating and executing 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.
In this position, you will work with US and international companies to develop/provide US and global regulatory strategies, guidance, and support. Key duties include coordination, planning, writing and preparation of documents for submission to FDA and international Health Authorities in support of investigational and marketing applications. The Senior Regulatory Project Manager will be responsible to communicate with the client throughout the project, establish timelines, agree on content and format of the submission, review/assess submission documents. Successful candidates will represent domestic and international companies as their designated regulatory/US agent; assist in the preparation of investigational and marketing applications and milestone meeting packages; coordinate and participate in meetings with FDA on Sponsor’s behalf.
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 (21 CFR, FDA and ICH or other regulatory agency guidance requirements). Successful candidates must have excellent written and verbal communication skills, strong organizational and leadership skills, and attention to detail. The Regulatory Project Manager position requires 3-5 years of pharmaceutical and/or regulatory experience; prior technical/report writing experience is a plus. RAC and/or Master's degree in a scientific discipline preferred.
Additional Salary Information: salary, vacation, bonus, 401K savings and profit sharing plan, health, disability and life insurance
Internal Number: BH-RPM
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 50 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.