Regulatory Affairs Specialist III

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

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

Qualifications

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

Additional Information

Best Regards,

Anuj Mehta

973-967-3402