What are the responsibilities and job description for the Regulatory Affairs Manager - Generic Pharmaceuticals position at Key Corporate Services, LLC?
Have you spent time in the R&D lab and have Regulatory experience as well? Want to work with a variety of drug products 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. We are looking for someone who has 4 years pharma R&D experience along with regulatory experience as they have many ongoing projects in R&D
Why You Want To Work Here
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. We are looking for someone who has 4 years pharma R&D experience along with regulatory experience as they have many ongoing projects in R&D
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
- Must have 5 years of pharmaceutical development experience in a regulatory role
- 4 years in R&D
- Are NOT only involved in Annual Reporting in Regulatory
- Must have experience working DIRECTLY with the FDA and other regulatory agencies
- 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
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