Regulatory Manager - Innovativ Pharma, Inc.

Job Overview
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

Essential Functions

• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).

Qualifications 

• Equivalent combination of education, training and experience.
• Full knowledge of drug development process
• Full knowledge of applicable regulatory requirements, SOPs, and company's Corporate Standards
• Strong knowledge of budget management and resourcing
• Considerable working knowledge of medical terminology
• Strong knowledge of Microsoft Office and e-mail applications
• Effective communication, organizational, interpersonal, and leadership skills
• Strong negotiation skills
• Ability to independently coordinate and manage new processes
• Ability to work well within a matrix team environment
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.