Description
Director, Regulatory Affairs
FULLY REMOTE
Assignment through Temporary Agency - Approximately 6 Months
Approximately 40 Hours Per Week
Job #26-01AT / #26-01A
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.
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
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
Mapp's 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 that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. 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.
If your job responsibilities allow, you may choose to work remotely. Willingness to Travel (Domestic Travel = Approximately <20% but varies + International Travel = Approximately <10% but varies) will be required for this position.
Mapp invites you to apply by submitting 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. Mapp utilizes E-Verify.
Mapp is an equal opportunity employer and employment decisions are not based on any protected status. Mapp uses a wide variety of advertising and outreach to find qualified applicants for employment.
Mapp is an Equal Opportunity Employer/Veterans/Disabled.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.
https://mappbio.applicantpro.com/jobs/4119580-960382.html
