Job Summary
The Director of Regulatory Affairs position will serve as a key member of the Regulatory team and may provide regulatory support across all disciplines, as needed. This role will be responsible for assisting in all regulatory strategies, writing, and activities for the organization, including all communications with FDA and other regulatory bodies. Additionally, the Director will assist as a steward of the Regulatory Affairs processes, procedures, and compliance to facilitate effective execution by the regulatory function across the organization.
About Mapp Biopharmaceutical
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
Responsibilities
- Ensures that all regulatory goals are met and are in compliance with current industry standards and global regulations, and are effectively networked with government funding stakeholders
- Serves as a steward of Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the Mapp organization
- Contributes to coordination, preparation, and timely submission of all regulatory documents
- Develops regulatory strategies (in consultation with the Head of Regulatory Affairs) for the company as well as for product development teams and may act as a key member of the product development teams at Mapp
- Facilitates FDA interactions, presentations and negotiations and assists with interactions with Health Authorities
- Interprets and disseminates FDA (and other regulatory body) communications, expectations and decisions to internal and external stakeholders (including CRO's, consultants and contractors) on a timely basis
- Advises the Head of Regulatory Affairs, senior management, and program team members on the impact of the changing regulatory environment can/will have on Mapp business and projects, including interpretation of regulations and guidance from governing agencies
- Assists in providing direction to regulatory team members related to assignments, timelines, and prioritization of project goals
Basic Qualifications
- Bachelor's degree in a related field; advanced degree or equivalent preferred
- 10 years of experience in technical/regulatory roles in the pharmaceutical/biotech industry
- 5 years of experience in Regulatory Affairs in pharmaceutical/biotech industry
- 3 years of demonstrated success in a regulatory leadership role and proven management by influence
- Direct experience with FDA interactions, including written and verbal interactions and negotiations
- Direct experience in writing and crafting regulatory submissions
- Demonstrated experience managing complex virtual and matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
- Demonstrated experience in developing effective and successful regulatory strategies for all aspects of development programs
- Thorough drug development technical expertise across Pre-Clinical and/or Clinical disciplines, and CMC
- Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner
- Ability to provide effective project communications, verbal and written, tailored for specific audiences
- Ability to translate complex information into a logical and credible plan
- Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities
- Demonstrated organizational skills and attention to detail
- Familiarity with eCTD requirements and e-submission formats/processes
- Experience in establishing portfolio and program Regulatory strategy from pre-Candidate Selection through Post-Licensure
Preferred Qualifications
- Direct experience in leading a monoclonal antibody/protein therapeutic through the drug development process through BLA submission, approval, and launch of the product
- Experience in commercialization of monoclonal antibody therapies
- Advanced degree or equivalent in a related field
- Experience in interacting and negotiating with non-US Regulatory Agencies
- Experience with post-approval change management, comparability assessments, post-marketing commitments and overall product life cycle management
- Experience with FDA Animal Rule requirements for licensing drugs
- Experience with US government acquisition and procurement contracting and Project Management deliverables
- Experience in supporting US Government grant or proposal planning and writing
- Previous experience establishing effective working relationships in a virtual environment
- Previous experience with mentoring and/or development of employees
- Previous experience developing drugs for rare diseases/Orphan drugs
- Previous experience with FDA's regulations on expanded access and/or emergency use authorization of investigational drugs
- Previous experience working with regulatory authorities in developing countries and in resource limited environments
- Ability to effectively work remote/virtual (if applicable) using telecons and web conferences to both interact with product development teams and senior management
