Regulatory Strategist-Director/Senior Director
Menlo Park, CA US
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 tomorrow's most innovative cancer therapies.
- Develop and implements regulatory strategies for assigned programs, in order to support Company's 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.
- Support in the preparation of the Regulatory Affairs department budget.
Qualifications, Education & Experience
- Bachelor's degree in chemistry, biochemistry, pharmacy, pharmacology, or related scientific discipline required.
- Master's 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
- Radio expertise
- 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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.