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, 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 in biologics 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.