Regulatory Coordinator

Full Time, Temporary/Contract/Project, Employee Job Category: Biotech/R&D/Science Relevant Work Experience: 2+ to 5 Years Career Level: Experienced (Non-Manager) Company: Devon Consulting Contact: Steven Horner Phone: 610-964-5772 Reference Code: D8456 Regulatory Coordinator Job Responsibilities:- The Regulatory Coordinator is the support function that supports the global regulatory affairs health authority liaison in 1-2 therapeutic areas. Required Skills:- A minimum of 1-2 years of clinical drug development or regulatory affairs experience in the pharmaceutical or biotech industry. - Global submissions experience an asset. - Basic understanding of Regulatory Affairs and drug development (IND, CTA, CTD, NDA/BLA, MAA, ICH & GCP).- Strong interpersonal and negotiation skills.- Well developed communication skills, verbal and written.- Proven ability to work in a complex matrix environment and with global teams.- Ability to meet tight target dates in a pressured environment is essential.- Demonstrated ability to perform multiple projects simultaneously.- Ability to organize and prioritize work assignments and projects.- Ability to work with moderate supervision.- Expert in the use of Microsoft Office Suite (MS Word, Excel, PowerPoint), Adobe Acrobat; MS Project experience a plus-Proficient in electronic regulatory submissions and document management (Documentum).- Bachelors of Science degree, preferably in pharmaceutical-related scientific discipline. Masters degree, regulatory experience and/or experience in oncology or biologics drug development preferred.Please send resumes to Steven Horner at Shorner@devonconsulting.com   Find An IT Job Find A Clinical Job Click here to learn about the benefits provided to Devon Consultants