Regulatory Affairs Manager

Looking for a unique approach to Regulatory Affairs? Want to push boundaries and bring life-saving medicine to the marketplace? This is the role for you!

My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic APIs, drug products, and certain med devices. This key role will report to the Senior Director of Regulatory Affairs. This role is a hybrid role with multiple sites across the globe.

Why you want to work here:

• Opportunity to get creative with regulatory submissions, no straight-forward box-checking
• Multinational company with sites across the globe
• Excellent ex-FDA leadership
• Fantastic pay and work-life balance

You'll be a great fit if:

• Must have 5+ years of pharmaceutical development experience in a regulatory role
• 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 week
• Must enjoy being creative with scientific data to find solutions without box-checking