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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The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of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.
Biotechnology, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Director, Regulatory Affairs, (Global Strategy)
My client is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases. Its pioneering research platform leverages the powerful biology behind the body’s ability to rebuild and repair its own cells and tissues. This approach to drug discovery has generated four therapeutic candidates that are currently in clinical trials. The Company’s lead therapeutic candidate is being evaluated in Phase 3 studies for the treatment of the hematologic diseases under a global partnership with a leading Biotechnology company.
In this high visibility role s/he will develop regulatory strategy for assigned programs. Lead the planning and preparation of global regulatory submissions (eg, INDs, CTAs, IND safety reports, meeting requests) As the primary regulatory representative to your programs s/he will provide strategic regulatory guidance to project teams and sub-teams and have direct supervision of an experienced Regulatory Affairs, Lead.
Serve as the liaison between the company and regulatory agencies for assigned projects
Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies
Prepare regulatory development plans for assigned projects
Develop and maintain regulatory knowledge of US, EU and ROW regulations
Coordinate and prepare responses in response to Regulatory Agency requests
Perform literature searches, prepare special reports and assemble documentation to support project teams
Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
Maintain active INDs/CTAs (amendments and annual reports)
Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
Minimum of 8 years’ experience in a biotech and/or pharmaceutical environment, including 4-5 years in Regulatory Affairs with strategy experience working with small molecules and/or biologics.
Minimum requirement of a BS in a scientific discipline
Employer will assist with relocation costs.
Additional Salary Information: 20% bonus, plus stock options