Senior Director, Regulatory Affairs (CMC)

Location
Summit, NJ
Posted
Jul 03, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

 Senior Director, Regulatory Affairs CMC

Hurley Consulting Associates, Ltd. is seeking a CMC Regulatory Affairs professional to join our Regulatory Affairs group.  M.S. or advanced degree preferred with at least 15+ experience in areas such as R&D, CMC and Quality Assurance in the pharmaceutical industry.

The responsibility will include: 

Prepare or review CMC technical documents, CTD Module 2, 3 and Module 3 for submissions.

Review of CTD Module 2.3 and Module 3 for technical content and compliance with regulatory requirements.

Participate in the development of global CMC regulatory strategies. 

Manage novel compound contract manufacturing for drug substances and drug products 

Knowledge of CMC, FDA, EMA and ICH guidelines.

Experience with IND preparation and IND amendments, NDA submissions and supplements and CTD format and electronic submissions.

Experience in management of multiple projects.

Analytical chemistry experience a plus.

RAC is a plus.

 

Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance and 401(k) plan.  Remote (optional).