FierceBiotech and FiercePharma Jobs
Director, Regulatory Affairs - Pharma - NJ - Advantage ONE Executive Search
Nov 04
Location: Paramus, NJCategories: Clinical
Position Description
Excellent opportunity to join a young and dynamic biopharma division of an international chemical company. They are the perfect size, small enough to offer excellent VISIBILITY and a real opportunity to IMPACT the success of the company, but large enough to provide all the resources needed and above average security (not VC funded). Great opportunity to apply your knowledge and experience to design, establish and build a Regulatory Affairs function. If you are weary of all the bureaucracy in big pharma this could be the perfect opportunity for you.
Reporting to the CEO, primary responsibility to prepare, assemble, review, and/or evaluate eCTD format FDA submissions (INDs, NDAs) amendments and supplements, annual reports, and additional documentation, as needed), as well as perform all required functions as Regulatory project lead for assigned products.
Develop and communicate regulatory strategies to other internal departments and external vendors and partners, with the goal of achieving the shortest possible time from project inception to product launch.
Responsible for reviewing acceptability of documents for submission, and communicating with other internal departments and external vendors and partners to assure submission timelines are met.
Review and approve internal change control documentation, promotional materials, MSDS, etc.
Travel Requirements: Limited domestic and foreign.
Position Requirements:
PhD degree in a scientific field with 8+ years of pharmaceutical regulatory affairs experience; or MS and 10+ years of experience. EU regulatory affairs experience would be a plus. Must have knowledge of current regulations related to the filing, approval process, and maintenance of submissions. Knowledge of CMC regulations also required. Must demonstrate a solid understanding of pharmaceutical product development plus FDA regulations and guidelines.
If fully qualified, reply in confidence with your resume attached as an MS Word doc to lvaughn@advantage-search.com
