Offer summary

Qualifications:

Experience in Regulatory Affairs, particularly in Merger & Acquisition and data migration., Strong project management skills with the ability to gather requirements and communicate effectively., Proven ability to think creatively and represent workstreams in a collaborative environment., Familiarity with Veeva Vault RIM and HP Application Lifecycle Management (ALM) is preferred..

Key responsibilities:

Lead conversations to gather requirements and identify risks from business stakeholders.

Represent the IS Regulatory Affairs workstream and provide regular project updates to the program team.

Ensure compliance with cross-functional requirements during data import/export into the Veeva RIM system.

Coordinate with the migration team and manage project plans to ensure timely delivery of work.

RxCloud is a professional services organization focused exclusively on Pharma, Biotech and Medical device industries. We are a full-scale Quality Assurance Organization driving innovation & ensuring compliance across the industry. Our mission is to deliver Quality, Compliance, Innovation, Customer Experience, and speed that enables global Life Science industry to continuously innovate and significantly reduce drug development life cycle. We are specialized in providing the CSV services, GxP Audits (GMP, GDP, GLP, GCP, GVP) as a service, Veeva Services, Software Quality Assurance services. Our full spectrum of service offerings includes QMS Consulting, End to End Global Audit Management, CAPA management, SOP Authoring, QA as a service. RxCloud’s differentiation is bringing in speed and agility to achieve compliance first time and every time.

Job description

JD:

Business Analyst with Regulatory Affairs Merger & Acquisition experience, Regulatory data migration experience who can manage and execute project, gather requirement, collaborate, efficiently communicate, and represent IS Reg Affairs workstream to program and have proven ability to creative thinking.

Responsibilities:

Efficiently lead the conversation, gather requirements from Business, understand the concerns, identify the risk, and communicate it promptly.
Represent the IS Regulatory Affairs workstream to the broader Program team, and responsible for providing project updates/statuses on a regular basis
Ensure document/data imported/exported into/from the Veeva RIM system by following multiple cross-functional requirements (e.g., Security, Quality, cross-functional Business, Legal)
Coordinate with the migration team to execute data migration/export into/from Regulatory Affairs/relevant systems
Create a project plan, manage, and execute it. Work with the Onsite-Offshore team and ensure delivery of work on time.
Work with multiple vendors to execute the project.

Preferred: