Manager, Regulatory Affairs

Hurley Consulting Associates, Ltd. is seeking a Manager of Regulatory Affairs professional to join our Regulatory Affairs group.  Bachelor’s degree, preferably in the sciences or advanced degree with at least 3-5 years pharmaceutical industry in the preparation of INDs, NDAs, or BLAs.  The Manager of Regulatory Affairs is required to have excellent written and oral communication skills and knowledge of FDA, ICH, and EMA guidelines,

The responsibilities include:

• Preparation of regulatory submissions including INDs and IND amendments
• Assist in the preparation of NDAs and BLAs
• Preparation and management of submission compilation plans

Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance and 401(k) plan and support for RAC certification.