Unique opportunity to expand your regulatory skill set and expertise to include direct interactions with FDA and submission of investigational and marketing applications that will make differences in peoples’ lives. Take charge of your career by joining our team as a Regulatory Affairs Project Manager.
B&H Consulting Services, Inc., located in central New Jersey, provides global regulatory affairs and CMC technical writing expertise to more than 60 US and international clients that range from Top 10 pharmaceutical and biotechnology companies to small, virtual start-ups. Our team interacts with FDA on a daily basis as US/regulatory agent for more than 45 companies. Founded in 1988, the company has grown to its current level of 15 employees and is seeking qualified individuals to fill two (2) new full-time positions within our expanding organization.
The successful candidates will be responsible for the strategic planning, coordination, writing, preparation and or assessment (gap analysis) of regulatory documents for global investigational and marketing applications. The organized, detail-oriented professionals we select will communicate with their clients throughout the project, establish timelines, agree on content and format of the submissions, review/assess documents for completeness, interact with health authorities, write summary documents, provide filing strategy and manage multiple activities to support each submission. They will represent international and US companies as their designated US/regulatory agent, work with clients to prepare meeting requests and briefing packages, and coordinate and participate in meetings with FDA on the sponsor’s behalf.
- Bachelor’s degree in a scientific discipline; RAC certification highly desirable
- 4-6 years of regulatory affairs experience or experience within R&D with an understanding of the regulatory/drug development process
- strong understanding of 21CFR and ICH including regulatory and compliance guidelines
- experience with CTD; knowledge of eCTD
- ability to interpret and apply regulations as they apply to specific project issues
- excellent technical writing and verbal communication skills
- proven ability to meet project timelines, serve on client project teams, and use computers effectively while maintaining confidentiality
Along with a competitive base salary and 401k/profit sharing plan, B&H offers a year end performance-based reward. B&H also offers employee health, dental and life insurance plans, Committed to work/life balance, B&H provides paid sick and vacation time as well a paid time off between Christmas and New Year’s Day. For strictly confidential consideration, please send cover letter and resume to email@example.com.