ELC GROUP is one of the most reputable regulatory affairs organizations in Europe and a leading provider of Regulatory services to Pharmaceutical, Biotech, Generic, and Medical Device companies supporting their clinical development, pre & post marketing obligations.
We provide customised solutions which ensure fast and successful development, authorisation or maintenance of our client's products.
ELC GROUP Regulatory team provides a global service offering with offices located in Prague (Czech Republic), Ahmedabad (India) and Cambridge (UK). Our Regulatory Affairs team is a highly experienced group of professionals who have the expertise to help develop your research into revenue.
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
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