As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
The Director, Regulatory Affairs has the responsibility for driving and developing the US regulatory business especially aimed at clients based inside the US whose interest is in filing with the FDA. The Director provides expert advice/strategy and opinion to clients within the US Regulatory environment. This position is a management, business and expert role.
Provide strategic direction and management for clients on US regulatory issues.
Effectively oversee the preparation of regulatory submission documents in adherence with applicable Regulations and Directives for submission to government agencies (focus on the US).
Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project team. Building positive working relationships with clients and government agency contacts.
Review and/or create study reports, clinical protocols, safety and efficacy reports for accuracy and compliance to regulations. Review of draft submissions for regulatory content and the editorial viewpoint.
Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
Lead and participate in formal interactions (face-to-face meetings, teleconferences, etc.) with clients and government agencies. Build positive working relationships with clients and government agency contacts.
Interact with potential clients to develop new business and create win-win agreements.
Identify project issues and develop alternate strategies for presentation to client. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
Participate in or conduct quote preparation and new project / client consultations.
Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers, advising on regulatory issues and strategies.
Present industry related training seminars or workshops at industry conferences.
Participate in the planning and execution of the strategic direction for the US business.
Significant experience of pharmaceutical / biologics development in the US regulatory environment, including leadership and/or senior consulting experience.
Expert knowledge and understanding of the development process for pharmaceutical and Biological products including: CMC, non-Clinical and Clinical
Working knowledge of venture capital and credit markets and their role in drug development
Strong knowledge of a variety of computer programs including MS Office, Adobe Acrobat, and eCTD compiling software, EDMS systems
Displays full knowledge of protocol, regulatory requirements, and company SOPs. Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety.
Mapi is the leading Patient-Centered Research company serving academia, life science researchers, and the pharmaceutical industry for over 40 years. Mapi’s commitment to patient-focused research is demonstrated not only by our expertise and nearly four decades of service but also through our direct contribution back to the industry. Mapi is among only a handful of global organizations that is capa...ble of engaging with a patients’ complete ecosystem, their HCPs, Patient Communities, payers, and even regulators. And only Mapi has the unique history to make us the most experienced at interacting with all of them.