Regulatory Affairs Manager

About the Company:

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.