Hamlyn Williams has partnered with an exciting Pharmaceutical company, based in New Jersey, in their search for an Associate Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects, primarily focused in novel therapies in the oncology space. 

Job Description:

• You will be responsible for managing CMC development and post marketing 
• Responsible for developing and executing strategy and submissions 
• Leading health authority interactions for both the US and EU interactions 

Qualifications:

• A MS/PhD degree in a related scientific discipline
• 8+ years of pharmaceutical industry experience         
• 4+ years of CMC experience
• Experience with preperation, management and review of filings such as: NDA, MAA and BLA with both the FDA and EMA 

Apply here or email a.mckenna@hamlynwilliams.com if you are interested in working with a leading organization in the industry.