Regulatory SME

Note

Description:

As a Senior Consultant, for regulatory operations, you will have responsibility to collaborate, manage and deliver on regulatory programs. You will be the subject matter expert in regulatory information and content migration working with a delivery team that spans both business and technical areas. You will need to ensure the regulatory data are identified and categorized correctly and moved to the proper application. You will oversee client deliverables to ensure they meet customer expectations and compliance regulations. You will be responsible for collaborating across the delivery team, including program managers and regulatory analysts, to ensure the accuracy and quality of the migrations. You will actively contribute to business transformation, process optimizations and solution design. This role will contribute positively to developing business relationships with clients and stakeholders with the goal of creating new and expanded business.

Duties & Responsibilities:

Will be responsible for delivering regulatory analysis and regulatory operations expertise for regulatory information and document management (including RIM/regulatory systems), regulatory processes, and RIM assessments/implementations/support programs.

Required qualifications to be successful in this role:

M.Pharm/B.Pharm, BE in Biotechnology

Technologies required:/ Selected Skills:

• 8+ years of Regulatory Operations and Regulatory Information Management experience.
• Knowledge of drug development and approval process.
• Strong understanding of global R&D submission process and requirements including eCTD publishing principles and various application types (IND/CTA, NDA, MAA, NDS etc.)
• Knowledge of Global Regulatory guidelines and Processes (US / EU / APAC / etc.)
• Demonstrated consulting experience, preferred.
• Experience working with applications for projects and regulatory activities (e.g. Veeva RIM, Documentum, SharePoint, IQVIA/ArisGlobal/Ennov, LORENZ docuBridge etc).
• Knowledge of Regulatory (eDMS, Archive and RIM) systems including cross-functional usage requirements, business administration and best practices.
• Medical Devices Regulation
• Experience in gathering and documenting requirements, business process analysis, change management concepts, current/future state analysis.
• Regulatory content migration experience a plus.
• Program Management and delivery experience a plus.
• Client engagement and relationship building skills a plus
• Conceptual thinking as well as analytical and problem-solving skills
• Strong communication skills, both verbal and written, at all levels
• Demonstrated ability to effectively collaborate with cross-functional virtual teams