Role: Senior Consultant/SME – Regulatory’

Exp. – 3yrs +

Share your resume at abir.chowdhury@arisglobal.com
•  Have excellent English writing skills, strong verbal and communication skills
• Work effectively in a team setting, ready to take over additional responsibilities
•  Contribute to cross-functional working groups as needed Functional and IT skills.
•  Ability to deal with the inherent ambiguity related to requirements definition and analysis, and exercise good judgment in line with the company’s overall goals
•  Excellent analytical skills and creativity in proposing multiple options/solutions to a requirement, and select the best based on customer business requirement
• Ability to simultaneously work with multiple stakeholders across the organization
•  Good understanding of Drug Safety and Regulatory requirements
•   Good training/Mentoring skills

Other Skills        
• Experience in working with customers to understand their business requirement and convert these into Requirements Documents
•  Understanding of product life cycle management
•  Experience in drug safety domain, including documentation review, implementation and testing activities
•   Drug Development Life Cycle
•   21 CFR Part 11
•   ICH-GCP
•   GAMP 5
•   Good Documentation Practices
•    Pharmacovigilance