Our client, a leading research intensive pharmaceutical company is looking for a qualified, experienced, and career avid regulatory affairs professional who will be functioning as a development team member.  This is a newly created position which will report to the Chief Scientific Officer.

Qualifications:

• Bachelor degree in science or related disciplines. Pharmacy degree preferred, but not required
• At least 5 year regulatory affairs experience in early product development with US regulatory bodies(3 years for specialist)
• Experienced in preparing and submitting various regulatory packages to the US FDA including pre-IND, IND, and NDA
• Good communication and people skills
• Capable of working in a multicultural environment

Job Description

• Show leadership in drafting and implementing the regulatory strategies for products that our client is developing
• Responsible for preparing the regulatory submission packages
• Negotiate and communicate effectively with the regulatory authority to obtain timely product approvals
• Join in the development teams and work as a team member to provide the deliverables specific to each regulatory requirement. The development teams will consist of, but are not limited to: research laboratory, clinical research, manufacturing, and business development unit.
  

Please email your cover letter and resume to ruth@pharmacruiting.com