Director, Regulatory Affairs

About the role

Mapp Biopharmaceutical, Inc. is a San Diego-based biopharmaceutical company dedicated to developing life-saving monoclonal antibody treatments for 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) are responsible for executing high-quality research and development activities to achieve a robust product pipeline through various stages including CMC, Nonclinical, Regulatory, Project Management, and Clinical activities.

Responsibilities

• Serves as a key member of the Regulatory team and may provide regulatory support across all disciplines, as needed.
• Affords assistance in all regulatory strategies, writing, and activities for the organization, including all communications with FDA and other regulatory bodies.
• Assists as a steward of the Regulatory Affairs processes, procedures, and compliance to facilitate effective execution by the regulatory function across the organization.
• 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.
• 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.

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 CMA
• 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
• 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

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 CMA
• 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
• 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

Skills

• 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
• 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

Benefits

Mapp offers a comprehensive benefits package including Medical, dental, and vision insurance benefits, basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full-time employees will receive 7 days of sick time, 13 paid holidays, and accrue 18 days of vacation throughout the calendar year.

Pay

The anticipated pay scale for this position is $130,000 to $250,000. The final salary offered to a successful candidate will be dependent on several factors including the candidate's level of education, type and length of experience within the job and/or within the industry.

Schedule

Currently this opening is a temporary position only through an agency, although if it converts to regular Mapp employment, the following benefits would apply:

• Medical, dental, and vision insurance benefits are available to eligible employees and their families.
• Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees.
• Full time employees will be provided 7 days of sick time, 13 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.

Application

To apply, please submit your information through the Mapp Biopharmaceutical, Inc. Job Openings website page. This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page. No Solicitors, agents or placement agencies please.