Hamlyn Williams has partnered with an exciting Pharmaceutical company, based in New Jersey, in their search for a Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects, including developing and implementing global regulatory strategy and life cycle management of said projects.

This is an opportunity to join a very passionate and close-knit team. The Director of RA will be a critical member on many projects and responsible for their individual contributions as well as a potential future team. 

Responsibilities

• Developing global product regulatory strategy to efficiently obtain approval by regulatory agencies for a variety of projects simultaneously 
• Communications with the health authorities
• Leadership in preparation of regulatory filings for submissions including: IND applications, meeting requests, post-marketing commitments and annual reports  
• Reviewing global marketing applications, clinical study reports, investigator brochures before release 
• Conducting initial IND and Clinical Trial Applications (CTA) content review and approval 
• Manageing regulatory project aspects including strategy, resources, costs, time and vendors

Qualifications

• 5+ years of experience in pharmaceutical regulatory affairs experience 
• Demonstrated experience with IND, NDA, GCP, ICH and other regulatory guidance requirements  
• Ability to manage multiple responsibilities with a high degree independence 
• Exceptional oral and written communication skills   
• MS or Doctoral degree in an applicable field of study 

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