Vice President Regulatory Affairs
Mapp Biopharmaceutical, Inc. is a 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. The Vice President of Regulatory Affairs will be responsible for developing and leading all regulatory strategies and activities for the organization, including all regulatory submissions. This includes ensuring that all corporate regulatory goals are met, are in compliance with all current industry standards globally, and are effectively networked with government funding stakeholders. The VP of Regulatory Affairs will serve as the global steward of Regulatory Affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This role will have oversight of an internal Regulatory team, be a key member of the development leadership team at Mapp and will report directly to the Chief Operations Officer.
- Bachelor's degree in related field
- 15+ years of progressive related experience in regulatory affairs in pharmaceutical/biotech industry
- 5+ years of demonstrated success in regulatory team leadership role and proven management by influence
- Prior monoclonal antibodies or protein therapeutics BLA filing experience required
- Direct experience with FDA and international regulatory agencies required
- Demonstrated experience managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
- Demonstrated experience in developing effective and successful regulatory strategies
- Broad understanding and direct experience in leading a mAb/protein therapeutic through the Drug Development paradigm from pre-Candidate Selection through Post-Licensure to support a team through generation and execution of Regulatory strategies
- Must have direct experience in written and verbal interactions and negotiations with FDA
- Experience in establishing portfolio and program Regulatory strategy from pre-Candidate Selection through Post-Licensure
- Deep Drug Development expertise in a functional area such as clinical research development, non-clinical or chemistry, manufacturing and control (CMC)
- Experience in commercialization of monoclonal antibody therapies
- Experience in taking a mAb or protein-based therapeutic program to BLA submission, approval and launch
- 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
- 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 assessment, 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 in labor and capacity planning
- 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 to investigational drugs
- Previous experience working with regulatory authorities in developing countries and in resource limited environments
- Previous experience developing good working relationships with regulators at all levels of the FDA
- Ability to effectively work remote/virtual (if applicable) using telecons and web conferences to both interact with product development teams, direct reports, and senior management
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego or may have the opportunity to work remotely. Approximately 25% domestic travel and less than 10% international travel is required. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
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.