Most Loved Workplace® Certified JobDirector, Regulatory Affairs
Most Loved Workplace® Certified JobAbout the Role
At MAPP, a Most Loved Workplace® certified employer in the Real Estate space, Managing £30 billion in commercial property with people-first excellence.
Director, Regulatory Affairs FULLY REMOTE Assignment through Temporary Agency - Approximately 6 Months Approximately 40 Hours Per Week Job #26-02AT / #26-02A 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. 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.
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Requirements
- 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
Benefits
- Medical, dental, and vision insurance benefits are available to eligible employees and their families
- Basic life insurance
- Short and long term disability
- 401K plan that includes Company contributions to eligible employees
- 7 days of sick time
- 13 paid holidays
- 18 days of vacation throughout the calendar year
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