Unigene Laboratories Inc. Work Values

Daily Duties at Unigene Laboratories Inc.:

• Assigned lead role to author and compile two CMC Drug Substance Type II DMFs following FDA and ICH guidelines by liaising with various departments within the company. • Successfully authored and compiled CMC Drug Product section in the eCTD format for a client’s Phase I IND submission by interfacing with various departments both within the company and with client personnel for a solid oral dosage form. • Participated in and successfully completed submissions of CMC annual reports and amendments for DMFs, INDs and NDA applications for all assigned clinical development and marketed products for submission to Health Authorities

What they like about Unigene Laboratories Inc.:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

Tags

CMC, Project Manager, NDA , Post Approval, Supervisor, CTD, Regulatory Affairs, RAC, Consultant, IND, Specialist

Skills

CMC, Management, Project Planning, Document Management Softwares, Cross-functional team management, CTD, eCTD, Regulatory Affairs, Post approval changes

These are some of the questions we asked our climbers about their experiences with Unigene Laboratories Inc.: