Director, Regulatory Affairs

Mapp Biopharmaceutical • San Diego, CA

1d • $130,000 - $250,000 • Remote

About The Position

Mapp Biopharmaceutical, Inc. is a San Diego-based biopharmaceutical company developing monoclonal antibody treatments for neglected and tropical infectious diseases and biodefense programs. Its Early Research and Development Group and Advanced Research and Development Group conduct research and development across CMC, nonclinical, regulatory, project management, and clinical activities.

The Director, Regulatory Affairs is a key member of the Regulatory team, providing regulatory support across disciplines as needed. The position assists with regulatory strategy, writing, and activities throughout the organization, including communications with the FDA and other regulatory bodies. It also helps maintain Regulatory Affairs processes, procedures, and compliance to support effective execution across the organization. The role works with product development teams, senior management, government funding stakeholders, and external parties, and may involve domestic and international travel.

Requirements

• Bachelor's degree in a related field.
• 10 years of experience in technical or regulatory roles in the pharmaceutical or biotech industry.
• 5 years of experience in Regulatory Affairs in the pharmaceutical or biotech industry.
• 3 years of demonstrated success in a regulatory leadership role and proven ability to manage by influence.
• Direct experience with FDA interactions, including written and verbal interactions and negotiations.
• Direct experience writing and crafting regulatory submissions.
• Demonstrated experience managing complex virtual and matrixed organizational structures and collaborating and influencing across such an organization.
• Demonstrated experience developing effective regulatory strategies for all aspects of development programs.
• Thorough drug-development technical expertise across preclinical and/or clinical disciplines, and CMC.
• Ability to interpret, communicate, and present regulatory information clearly, concisely, and in a timely manner.
• Ability to provide effective verbal and written project communications tailored to specific audiences.
• Ability to translate complex information into a logical and credible plan.
• Ability to work independently with minimal supervision and in a team environment with changing timelines and priorities.
• Demonstrated organizational skills and attention to detail.
• Familiarity with eCTD requirements and e-submission formats and processes.
• Experience establishing portfolio and program regulatory strategy from pre-candidate selection through post-licensure.

Nice To Haves

• Direct experience leading a monoclonal antibody or protein therapeutic through drug development, BLA submission, approval, and product launch.
• Experience commercializing monoclonal antibody therapies.
• Advanced degree or equivalent in a related field.
• Experience interacting and negotiating with non-U.S. 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 U.S. government acquisition and procurement contracting and project management deliverables.
• Experience supporting U.S. Government grant or proposal planning and writing.
• Previous experience establishing effective working relationships in a virtual environment.
• Previous experience mentoring and/or developing employees.
• Previous experience developing drugs for rare diseases or orphan drugs.
• Previous experience with FDA regulations on expanded access and/or emergency use authorization of investigational drugs.
• Previous experience working with regulatory authorities in developing countries and resource-limited environments.
• Ability to work effectively remotely or virtually using teleconferences and web conferences to interact with product development teams and senior management.

Responsibilities

• Ensure regulatory goals are met in compliance with current industry standards and global regulations, and are effectively networked with government funding stakeholders.
• Steward Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across Mapp.
• Contribute to the coordination, preparation, and timely submission of regulatory documents.
• Develop regulatory strategies, in consultation with the Head of Regulatory Affairs, for the company and product development teams; may serve as a key member of Mapp product development teams.
• Facilitate FDA interactions, presentations, and negotiations, and assist with interactions with Health Authorities.
• Interpret and disseminate FDA and other regulatory body communications, expectations, and decisions to internal and external stakeholders, including CROs, consultants, and contractors, in a timely manner.
• Advise the Head of Regulatory Affairs, senior management, and program team members about how changes in the regulatory environment may affect Mapp's business and projects, including interpreting regulations and agency guidance.
• Assist in providing direction to regulatory team members regarding assignments, timelines, and prioritization of project goals.

Benefits

• Medical, dental, and vision insurance benefits for eligible employees and their families.
• Basic life insurance.
• Short- and long-term disability coverage.
• 401(k) plan with Company contributions for eligible employees.
• Seven days of sick time for full-time employees.
• Fourteen paid holidays for full-time employees.
• Eighteen days of vacation accrued throughout the calendar year for full-time employees.
• Potential applicable bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Director