Manager, CMC Regulatory Affairs

Job Responsibilities:

· Write and compile pharmaceutical regulatory submissions to Federal and State agencies:

o  Chemistry, Manufacturing, and Controls submissions,

o  Site registration and licensing submissions,

o  Labeling submissions,

o  Annual and periodic reports

· Manage and record regulatory-related communications to and from the FDA and other agencies

· Manage on-site FDA inspections as well as on and off-site audits

· Review change controls and determine regulatory reporting category

· Review master batch records and validation protocols for conformance to current regulatory requirements

· Maintain compliance of labeling, including revision control and updated safety information

· Maintain and meet regulatory calendar for routine regulatory submissions and expedited reports

· Maintain up-to-date knowledge of regulatory initiatives and trends

· Communicate relevant regulatory issues and provide CMC-regulatory strategy and guidance to senior management

 

Qualifications:

· B.S. degree (M.S. preferred) in the natural or life sciences or healthcare-related area

· Minimum 3 years of regulatory affairs-specific experience, including work in the drug development and marketed pharmaceuticals CMC environments

· Prior responsibility for direct communications with the FDA Office of New Drugs/ONDQA

· Proven capability to oversee and manage all aspects of the regulatory compliance and submissions function, especially as regards CMC needs

· Firm knowledge of CMC-related FDA guidelines and regulations

· Experience with successful filing of pre-approval and post-approval FDA submissions

· Knowledge of, and experience at, implementing GLP and Pharmaceutical GMP regulations

 

Desired additional experience:

· Experience with EU and Rest-of-World regulatory affairs and submissions

· Knowledge of FDA Import/Export and Customs procedures

· Experience with medical device regulatory and quality

 

 

Overtime/travel required: minimal overtime/some travel required

 

JOB CODE: RD-0XX

REPORTS TO: Vice President, Regulatory Affairs