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Associate Director of Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC)
Location: San Diego, California
Type: Full Time
Required Education: 4 Year Degree
Internal Number: 1967909
Associate Director of Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC)
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 with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Associate Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for multiple therapeutics at various stages of development. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads multi-functional technical teams in relation to regulatory expectations. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. This position reports to the Head of Regulatory Affairs.
BS or BA Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Biologics, or another life-science related field - Advanced degree is preferred
10 years experience in the biotech industry or in a related field, or the equivalent combination of education and experience, with prior experience in a technical role in the CMC function, for example, as an analytical lead or downstream process (DSP), or upstream process (USP) lead for a mAb development program
2 years of experience in regulatory affairs in pharmaceutical/biotech industry with a focus on CMC activities and CMC Regulatory Affairs with demonstrated success and proven management by influence
Monoclonal antibodies or protein therapeutic IND and/or BLA filing experience
Experience with the FDA in regards to responding to CMC queries and/or requests
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 the CMC organization
Experience in leading the CMC activities of a mAb/protein therapeutic through the drug development process through IND and/or BLA submission
Experience in written and verbal interactions and negotiations with FDA related to CMC issues/submissions
Experience in establishing portfolio and program CMC Regulatory strategy from pre-Candidate Selection through Post-Licensure
Drug development technical familiarity in all aspects of CMC for Biologics
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
Advanced degree or equivalent in a related field
Experience in interacting and negotiating with non-US Regulatory Agencies
Experience in commercialization of monoclonal antibody therapies
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 establishing effective working relationships in a virtual environment
Previous experience developing drugs for rare diseases/Orphan drugs and/or antivirals
Previous experience supporting emergency use/expanded access interactions with FDA and other regulatory bodies
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 especially in CMC related areas
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
Ensures that all CMC 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 the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization
Participates in the development of regulatory strategies for the company as well as for product development teams
Drafts regulatory submissions pertaining to CMC development and assists technical team members in compilation of relevant material to support overall product development strategies
Acts as a key member of the product development, CMC and regulatory leadership teams at Mapp
Serves as the CMC regulatory representative to drug substance/product development teams and provide input to key development decision and documents
Acts as the primary point of contact with Health Authorities on CMC matters. Facilitates CMC interactions, presentations and negotiations and is responsible for the oversight of CMC interactions with Health Authorities as needed
Develops effective working relationships with the regulators at the leadership level and not just the transactional level
Interprets and communicates FDA (and other regulatory body) messages pertaining to CMC matters, expectations and decisions to internal and external stakeholders (including CRO's, CMO's, consultants and contractors) on a timely basis
Advises senior management on the impact the changing regulatory environment can/will have on Mapp business and projects
Participates in portfolio and program-level strategy establishment, decision-making, issue resolution, communications strategy, and resourcing/capacity evaluations as the CMC Regulatory Affairs representative
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility, or, if your job responsibilities allow, you may choose to work remotely (outside of the State of Colorado.). Willingness to Travel (~<20% = Domestic Travel + ~<10% International Travel) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer – Qualified 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.
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