Hurley Consulting Associates is seeking a Sr. Manager, 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 Sr. Manager is required to have excellent written and oral communication skills and knowledge of FDA, ICH, and EMA guidelines. Experience with docuBridge or Veeva Vault a plus.
The responsibilities include:
- Preparation of regulatory submissions including INDs and IND amendments
- Assist in the preparation of NDAs and BLAs
- Preparation and management of regulatory project plans and submission compilation plans
- Preparation and maintenance of regulatory files
Hurley Consulting Associates offers a competitive salary, health care benefits, group life insurance and 401(k) plan and support for RAC certification.