Excellent chance to join a cutting edge, virtual pharmaceutical company A global pharmaceutical company offering a variety of services and products, including both custom and generic API development, licensing, sourcing, distribution, supply chain management, and contracts manufacturing services. They are building out their Regulatory team with a Senior Manager of Regulatory Affairs. Why Join Their Team? Excellent leadership, including ex-FDA leaders Global presence in a virtual setting, unique value proposition Family owned company, nimble and aggressive in the marketplace Role Overview: In this position, reporting to the Director, Regulatory Affairs, you will be responsible for authoring premarketing regulatory submissions, including PINDs, INDs, NDAs, ANDAs, post-approval supplements, annual reports, and controlled correspondence, mainly in the CMC area. The Ideal Candidate Has: Demonstrated CMC lab experience 5 years in a regulatory setting Demonstrated experience with technical writing and presenting those findings to the FDA and EU authorities You’ll Receive: Competitive salary bonus Health insurance, dental, vision, life insurance, LTD 401(k) Long Term Incentive programs Please apply or reach out to Alex Halstead at alexhhobsonassoc.com or 203-439-7787 J-18808-Ljbffr