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Regulatory Strategist-Director/Senior Director
3 months ago
Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options. Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy What we look for At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are relentless in our focus to offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast paced company passionate about discovering and developing tomorrows most innovative cancer therapies. Develop and implements regulatory strategies and contingencies for assigned programs, in order to support Abderas development objectives. Lead and prepare FDA submissions. Participate in global project team meetings provide regulatory support and guidance and manage day-to-day regulatory activities. Provides guidance and expertise to senior management and other departments on all regulatory issues for the strategic development, planning, compilation and submission for all regulatory filings. Serve as the primary contact with FDA and liaise, negotiate and orchestrate all interactions with FDA. Provide mentorship to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application. Edit or lead the editing of scientific sections of regulatory documentation against the regulatory requirements. Assist with the writing, review and preparation of an IND application. Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence. Participate in due diligence activities and communicate regulatory risks before products/devices development, acquisition or in-licensing of new product or devices. Provides support on labeling and advertising matters. Maintain knowledge of regulatory environment, global regulations and guidance Contribute to the development and maintenance of Regulatory Affairs working practices and procedures Support in the preparation of the Regulatory Affairs department budge Qualifications, Education & Experience Bachelors degree in chemistry, biochemistry, pharmacy, pharmacology, or related scientific discipline required. Masters Degree, PharmD or PhD preferred. 10+ years of relevant experience in a similar role within the biotechnology or pharmaceutical industry 7 + years in regulatory affairs Ability to interpret and understand US regulations governing pharmaceutical industry. Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology. Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organization. Prior experience with FDA submissions required. Skills & Abilities Ability to critically review regulatory scientific documents across non-clinical and clinical disciplines. Builds a learning environment that recognizes the value of each contributor and promotes a solutions orientation. Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services. Willingness to collaborate with team to identify and implement in best practices for optimizing performance. Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. Strong leadership skills in leading team members and vendors. Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight. Strong organizational, communication and interpersonal skills Ability to prioritize, delegate and execute to meet project deadlines. Proactive, innovative, with excellent problem-solving skills. Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms). At ease in start-up environment and effectiveness to deliver in low-structured environments. Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. What's your citizenship / employment eligibility? * #J-18808-Ljbffr
