ELC GROUP looking for Regulatory Submissions Compiler and Publisher

Post: Regulatory Submissions – Compilation and Publishing

Job Description:

• Working within a team 18 associates your work will ensure that deliverables are produced that meet client expectations for quality and timeliness.    
• Anticipation and communication of project concerns.    
• To be a strong team player and to represents our provisions as a center of excellence    
• To understand current trends in global requirements for electronic compilation of regulatory applications in the pharmaceutical industry.    
• Supporting and aiding eCTD creation/compilation for different submission procedures (EU & US)     Communication and coordination with client to compile and make ready documents for regulatory applications.    
• Interaction with client to provide expertise in the area of electronic compilation of regulatory applications    
• Maintain knowledge of current trends of global requirements for electronic compilation of regulatory applications in the pharmaceutical industry    
• Resolution of client issues related to publishing regulatory submissions

Candidate Profile:
- Bachelor’s degree (preferred)    
- Experience in clinical studies or regulatory submissions publishing and/or operations (eCTD and other formats) within the EU or U.S. pharmaceutical industry is advantageous.    
- Strong interpersonal skills; demonstrated ability to work with colleagues and clients in a consistent professional manner.
- English language - Good verbal & written is required    
- Ability to Self-motivate    
- Ability to draw appropriate conclusions; propose solutions and/or correct actions.    
- Ability to organize and prioritize work and manage projects in a timely and effective manner.    
- Ability to travel occasionally

Additional Information: 
Education: B.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Regulatory Submissions