Director/Senior Director Regulatory
Abdera Therapeutics
- San Francisco, CA
- Permanent
- Full-time
- Develop and implements regulatory strategies and contingencies for assigned programs, in order to support Abdera’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.
- 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 budget
- 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.
- 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.