Regulatory Affairs Specialist III

Responsibilities:

• Author Module 3 submission documentation according to eCTD requirements for New Drug Application (NDA) Prior Approval Supplements (Client), Changes Being Effected (CBE-0 and CBE-30), and annual reports.

• Compile, review, and submit DMF annual updates, amendments, letters of authorization, and customer notifications.

• Participate in team meetings as a representative of IA with both internal and external cross-functional project teams.

• The Regulatory CMC Technical Associate may be called upon to author technical reports.

• The candidate must be able to adhere to local and global SOPs to meet pre-established project milestones and timelines

Skills:

• BA/BS in a scientific discipline - Chemistry or Biology are preferred

• Master s Degree a plus

• 4+ years of pharmaceutical regulatory affairs experience

• Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or IND submissions experience

• Expertise with Microsoft Office Suite, Electronic Document Management Systems

• Proven experience working with authoring templates and tools

• Excellent multi-tasking skills and ability to manage multiple competing projects while meeting

project timelines

• Required to communicate with management when issues arise

• Must have the appropriate technical background and desire to learn and assimilate new information

• Proven ability to work independently and as a member of a team

• Capable of interacting with technical groups and understand complex issues pertaining to CMC, packaging, and testing

• Superior written and verbal communication skills in the English language

• Excellent proofreading skills

• A working knowledge of cGMPs

• The potential candidate may be called upon to provide a writing sample

Best Regards,

Anuj Mehta

973-967-3402