Hobson Associates
Senior Manager of Regulatory Affairs
Hobson Associates, Trenton, New Jersey, United States,
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 leadersGlobal presence in a virtual setting, unique value propositionFamily 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 experience5+ years in a regulatory settingDemonstrated experience with technical writing and presenting those findings to the FDA and EU authorities
You’ll Receive:
Competitive salary + bonusHealth insurance, dental, vision, life insurance, LTD401(k)Long Term Incentive programs
Please apply or reach out to Alex Halstead at alexh@hobsonassoc.com or 203-439-7787
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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 leadersGlobal presence in a virtual setting, unique value propositionFamily 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 experience5+ years in a regulatory settingDemonstrated experience with technical writing and presenting those findings to the FDA and EU authorities
You’ll Receive:
Competitive salary + bonusHealth insurance, dental, vision, life insurance, LTD401(k)Long Term Incentive programs
Please apply or reach out to Alex Halstead at alexh@hobsonassoc.com or 203-439-7787
#J-18808-Ljbffr