RA Director Regulatory Affairs- Biologics- Clin/CMC
Location: Washington
Description: InVision is employing RA Director Regulatory Affairs- Biologics- Clin/CMC right now, this occupation will be placed in Washington. For complete informations about this occupation opportunity kindly see the descriptions. Seattle area Salary Range 120-170k
Regulatory Affairs Director
we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the oncology market. We are a global, research-based pharmaceutical company and our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network and a robust product pipeline and US revenues exceeding $2.6 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.
The scope of the North American Regulatory Affairs department involves the preparation, coordination, and strategic presentation of Regulatory documents to the FDA for registration and maintenance of new and existing products in the U.S. marketplace. The Director, Regulatory Affairs is a leadership role in the North American regulatory organization reporting directly to the V.P. of Regulatory.
The position will manage FDA liaisons responsible for regulatory strategy, tactics, and direction to new product development in preparation of submission documents, responses to queries by regulatory authorities and setting and developing processes to improve performance perpetually meeting the changing regulatory environment. This position is critical to improve the focus on preparing NDAs, INDs, sNDAs and other regulatory documentation through electronic methodology to meet improved regulatory review time. This position directly impacts the bottom line of the organization as identification of appropriate regulatory strategy can achieve earlier time to approval for development compounds and earlier sales of a product. The position serves as a focal point of information exchange between US Regulatory and the Global Regulatory Affairs functions and other ex-US national Regulatory Affairs Departments within the co.
This position includes the responsibility for preparing Advisory Committee presentations, establishing Advisory Committee regulatory support, budgeting, staffing, and outside contracting as required. Major Tasks of Position include the following: * Manages FDA liaisons and directly contacts FDA Divisions as liaison for Bayer Corp. to assure continuing follow-up to IND, NDA, sNDA etc to meet the companies need for timely submissions and approvals. * Directs staff to assure that clinical protocols, investigator brochures, toxicology reports, pharmacology, CMC and other components needed to prepare a filing or support a filing are available when needed and as needed to meet regulatory guidelines or the CFR. * Provides strategic input to project’s movement through the FDA review process. Develops strategic regulatory evaluation and direction for assigned Pharma therapeutic projects and submissions. * Interacts directly with Global Regulatory Affairs Therapeutic Area Heads and Global Regulatory Strategists to provide US input and recommendations into the global project teams and their development strategies. In addition, as many clinical trials which form the basis of new drug applications are conducted in the US, and the decisions of the US FDA are widely respected throughout the world, the incumbent interacts with ex-US National Regulatory Affairs Managers to assist in the approval process in their countries. * Supports marketed products by liaising with the FDA (external) and Medical/Marketing (internal) so that issues affecting the success of these products and their lifecycle are addressed appropriately. * Provides interaction with staff the interchange of preclinical and clinical information regarding products being developed in order that the Medical staff can be assured that all available information on any product is in-house and conforms to applicable regulations. * Supervises special projects as assigned by the VP Regulatory.
NOTES:
Requirements
Required Qualifications: * Requires PhD, PharmD, MD or equivalent and 10 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry. * The individual must have expert knowledge of all FDA regulations especially as they apply to preclinical and clinical disciplines to support filings. * A thorough working experience in a regulatory affairs department with knowledge of FDA divisions, personnel, and procedural concepts is mandatory. * Good communication skills, both verbal and written, are imperative. * Prior staff management of several personnel is required. * The incumbent should demonstrate the ability of bridging several scientific disciplines and of successful teambuilding. * The incumbent should have a thorough knowledge of the pharmaceutical industry and related government regulations with extensive experience in dealing with consultants and clinical investigators. * He/she must also deal with the needs of a consumer response group along with research and development. Sound leadership skills and demonstrated ability to guide projects to successful conclusions must be evident. * Must have the demonstrated ability to influence, to build relationships with regulatory bodies, and to successfully negotiate. * The demonstrated ability to work within a global team framework and a multi-cultural environment is required.
Desired Qualifications: * It is desirable that the individual have an in-depth knowledge of medical procedure, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials.
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This occupation starts available on: Tue, 24 Jul 2012 10:26:54 GMT
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