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This range is provided by Key Corporate Services, LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$150,000.00/yr - $175,000.00/yr
Additional compensation types
Annual Bonus
Direct message the job poster from Key Corporate Services, LLC
Well established European pharmaceutical firm that supports the pharmaceutical industry with Intermediates, API's, Drug Products and Medical Devices and Drug Delivery is expanding it's Regulatory team in the US.
About the Role:
We are searching for candidates with advanced (Ph.D./MS) degrees in Chemistry/Analytical Chemistry/Medicinal Chemistry/Pharmaceutical Science. 4-7 years Pharmaceutical R&D experience with Regulatory Submission experience. The person should be flexible, as we have many ongoing projects in R&D.
Qualifications:
M.Sc. or Ph.D. in chemistry, pharmaceutical sciences, chemical engineering, or related scientific field
Required Skills:
Must have pharmaceutical development experience and experience and have worked in a regulatory role writing submissions.
Preferred Skills:
Opportunity to work on a variety of projects for companies developing a wide range of molecules and drug products analytical reports validation reports FDA submissions pre IND NDA ANDA drug development drug substance characterization formulation prototypes hands on analytical stability issues
Multinational company with sites across the globe
Excellent ex-FDA leadership
Pay range and compensation package:
140000-175,000 Plus Annual Bonus
You'll be a great fit if:
M.Sc. or Ph.D. in chemistry, pharmaceutical sciences, chemical engineering, or related scientific field
Must have experience working DIRECTLY with the FDA and other regulatory agencies
Must have experience with pharmaceutical development aspects such as drug substance characterization, formulation development, process development, and analytical methodologies, with the ability to provide substantive input and offer solutions to CMC issues at various stages of drug development.
Experienced with the preparation and submission of regulatory documents, including PIND meeting packages, INDs, NDAs, ANDAs, regulatory correspondence, and amendments
Must be able to commute to the office in New Jersey once per month for team meetings
Strong problem solver.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing, Production, and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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