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

Mapp Biopharmaceutical

Open Positions at Mapp Biopharmaceutical

Director, Regulatory Affairs