Regulatory Consultants (Labeling and CMC)
Job Opportunity at Clinical Dynamix, Inc.

Posted on Apr 8

http://www.clinicaldynamix.com    888-558-2546

Location: Jersey City, NJ
Job Type: Contract
Job ID: W4121574

Leading Global Pharmaceutical Company is expanding and needs two different long term consultants for their Regulatory Team in Jersey City

the first is a Regulatory Affairs Consultant in the CMC division and the second role is a Labeling Specialist
They ALSO have additional Perm (FTE) roles if you are interested- please contact us
Reg Affairs Consultants: max pay rate is $40/hr Responsibilities: Support Regulatory Affairs CMC Manager in managing and maintaining regulatory documentation for approved regulatory applications and licenses. 
• Position requirements: Excellent organizational, communications, and document research skills a must. This position also requires teamwork, problem-solving, ability to multi-task and motivate resources in the gathering of information required. Comprehensive coordination and compilation of documentation. This person must be able to work independently with minimal guidance. Computer literacy is a must (e.g. MS Word, MS Excel, and Adobe Acrobat). 
• Education: Minimum BA or BS required, preferably in a scientific or health related discipline. 
• Experience: Minimum of 3 years experience in Regulatory Affairs CMC with a Pharma company. Understanding of related disciplines in a FDA regulated environment. Familiar with CMC-relevant FDA databases.
   
   
   
   
   
Labeling Specialist – Consultant Max pay rate is $35/hour + plus benefits

Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). Labeling documents include those prepared for FDA annual reports and submission labeling in compliance with regulatory requirements and within company timelines. 

Candidate will be required to work with limited oversight and have a basic understanding of FDA labeling regulations and FDA guidances to the level of applying them effectively to all work output. 
Specific responsibilities include: 
•Assisting labeling managers with overall labeling process of brand prescription products 
•Complete electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents 
•Periodic reports as per FDA requirements, including redlining, understanding of working in a digital workflow system, NDC number and assignment and associated FDA labeling related regulations for assigned products. 
•Conversion of label to structured product labeling (SPL) and update SPL as needed for CMC and labeling changes 
•Posting of correct labels to company websites 
•Maintain tools/lists that support the coordination with other functions (e.g., Quality, Manufacturing) to make certain only agency approved labels are produced for appropriate products 
•Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies 
•Additional labeling / organizational responsibilities as needed 

Qualifications 

•Education Required: BA/BS 
Education Required: BA/BS with a Scientific or Regulatory background 
•Experience Required: 2+ years of pharmaceutical labeling experience; scientific background or familiarity with medical terminology. 
•Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and Sharepoint. 

Job-specific Competencies: 
•Excellent written communication and organizational skills 
•Works cooperatively with others; can also manage tasks and priorities independently as needed. 
•Takes responsibility for his/her own performance; promptly notifies his/her manager about any problems that affect his/her ability to accomplish planned goals 
•Demonstrates flexibility in managing changing priorities and demands 

Knowledge of: 
• Food and Drug Administration (FDA) regulations and guidelines. 
• Current FDA/Regulatory Affairs submission requirements. 
• Logistics and work of the pharmaceutical industry. 
• Current Company policies, practices and procedures, including safety rules and regulations.

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